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NCT Number: NCT05172739

Opioid Free Anaesthesia-Analgesia Strategy on Surgical Stress and Immunomodulation in Elective VATS-Lobectomy for NSCLC

Lobectomy is a major, high-risk surgical procedure that in addition to one-lung ventilation (OLV) exerts a potent surgical stress response. An overwhelming immune cell recruitment may lead to excessive tissue damage, peripheral organ injury and immunoparesis. The effect of anesthesia on the immune system is modest, compared to the effects induced by major surgery. However, to an immunocompromised patient, due to cancer and/or other comorbidities, the immunosuppressive effects of anesthesia may increase the incidence of post-operative infections, morbidity, and mortality. Exogenous opioids have been correlated with immunosuppression, opioid-induced hyperalgesia, and respiratory depression, with deleterious outcomes. An Opioid-Free Anaesthesia-Analgesia (OFA-A) strategy is based on the administration of a variety of anaesthetic/analgesic and other pharmacological agents with different mechanisms of action, including immunomodulating and anti-inflammatory effects. Our basic hypothesis is that the implementation of a perioperative multimodal OFA-A strategy, will lead to an attenuated surgical stress response and attenuated immunosuppression, compared to a conventional Opioid-Based Anaesthesia-Analgesia (OBA-A) strategy. The aforementioned effects, are presumed to be associated with equal or improved analgesia and decreased incidence of postoperative infections compared to a perioperative OBA-A technique.

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Key information

About this study

Surgical manipulation and one lung ventilation (OLV) exert different and synergic effects to generate an inflammatory response during lung resection surgery. Surgery, such as lobectomies, often leads to severe immunosuppression that in turn can lead to infectious complications and sepsis. Both anesthesia-related and surgery-related perioperative measures may modulate the patient's immune response and lead to the activation of different components of the immune system. Anesthesia-induced activation, in particular of the adaptive immune system, may also induce persistent, postoperative immunosuppression. An overwhelming immune cell recruitment may lead to excessive tissue damage, peripheral organ injury and immunoparesis.

Opioid analgesia remains the corner stone of acute pain management in perioperative analgesic regimes. Opioid receptors are not only expressed in the central nervous system to regulate pain perception but also occur on immune and tumour cells. Exogenous opioid administration has been correlated with immunosuppression, opioid-induced hyperalgesia, and respiratory depression, with deleterious outcomes.

An Opioid-Free Anaesthesia-Analgesia (OFA-A) strategy is based on the administration of a variety of anaesthetic/analgesic and other pharmacological agents with different mechanisms of action, including immunomodulating and anti-inflammatory effects where at least one factor causes inhibition of central sensitization and at least another factor inhibits the peripheral sensitization of the nervous system, as a response to painful surgical stimuli. This combination of factors has to have a synergistic or additive effect so that best analgesic effects can be achieved with the lowest possible dosage.

Our basic hypothesis is that a perioperative OFA-A strategy on cancer patients undergoing VATS lung surgery for tumour resection will be accompanied by abolished or attenuated immunosuppression. The additional potential clinical implication of a perioperative OFA-A strategy is the avoidance of the onco-proliferative side effects of both exogenous and endogenous opioids, released by cytokine-mediated immune cell activation. Inflammatory response inhibition is expected to reduce the possibility of acute and chronic post-operative pain developement, compared to a perioperative Opioid-Based Anaesthesia- Analgesia (OBA-A) technique. Additionally, the aforementioned inflammatory response inhibition is expected to lead to an overall reduction of overall postoperative pulmonary complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing elective VATS lobectomy
  • early stage NSCLC (up to T3N1M0)

Exclusion criteria

  • Immunocompromised patients
  • previous lung surgery
  • preoperative corticosteroid or immunosuppressive drug use
  • uncontrolled Diabetes Mellitus
  • cardiac failure (NYHA 3 and 4)
  • preoperative infection (CRP >5mg/ml, WBC >10x10^9/L)
  • preoperative anemia (Hb<12g/dl)
  • chronic inflammatory diseases
  • inflammatory bowel disease

Group-specific exclusion criteria:

  • OFA-Α: perioperative opioid administration, within the study period
  • OBA-Α: perioperative dexmedetomidine or lidocaine infusion, ketamine, gabapentinoid or corticosteroid administration within the study period

Treatment and study plan

Opioid-Based Anesthesia-Analgesia Strategy

Drug

A perioperative Opioid-Based multimodal Anesthesia- Analgesia strategy will be implemented that incorporates the following pharmacological agents:

Premedication: Midazolam, Anaesthesia induction & maintenance: Midazolam, Propofol, Fentanyl, Cisatracurium or alternatively Rocuronium, Desflurane, Morphine, Paracetamol, Dexketoprofen trometamol, Ondansetron or Droperidol, Ropivacaine Surgical ward: Morphine, Paracetamol, Dexketoprofen trometamol Rescue therapy only: Tramadol

Other names: Opioid-Based Anesthesia, OBA-A

Opioid-free Anesthesia-Analgesia Strategy

Drug

A perioperative Opioid-Based multimodal Anesthesia- Analgesia strategy will be implemented that incorporates the following pharmacological agents:

Premedication: Pregabalin, Midazolam, Anesthesia induction & maintenance: Midazolam, Dexmedetomidine, Lidocaine, Propofol, Ketamine, Hyoscine, Cisatracurium or alternatively Rocuronium, Magnesium sulphate, Dexamethasone, Desflurane, Paracetamol, Dexketoprofen trometamol, Ondansetron or Droperidol, Ropivacaine, Surgical ward: Ketamine, Lidocaine, Clonidine, Droperidol and Midazolam, Pregabalin, Paracetamol, Dexketoprofen trometamol Rescue therapy only: Tramadol

Other names: Opioid-Free Anesthesia, OFA-A

Primary outcomes

  1. Neutrophil to Lymphocyte ratio (NLR)

    Time frame: Preoperatively

    Neutrophil to Lymphocyte ratio (NLR) is a prognostic index that predicts patients' overall survival. Higher NLR has been correlated with worse outcome.

  2. Platelet to Lymphocyte ratio (PLR)

    Time frame: Preoperatively

    Platelet to Lymphocyte ratio (PLR) is a prognostic index that predicts patients' overall survival. Higher PLR has been correlated with worse outcome.

  3. Lymphocyte to monocyte ratio (LMR)

    Time frame: Preoperatively

    Lymphocyte to monocyte ratio (LMR) is a prognostic index that predicts patients' overall survival. Lower LMR has been correlated with worse outcome.

  4. Advanced Lung Cancer Inflammation Index (ALI)

    Time frame: Preoperatively

    Advanced Lung Cancer Inflammation Index (ALI) is a prognostic index that predicts patients' recurrence-free survival and overall survival. ALI is calculated as (BMI x Alb / NLR) where BMI = body mass index, Alb = serum albumin, NLR (neutrophil lymphocyte ratio, a marker of systemic inflammation). Higher ALI scores have been correlated with worse outcome.

  5. Systemic Immune Inflammation Index (SII)

    Time frame: Preoperatively

    Systemic Immune Inflammation Index (SII) is a prognostic index that predicts patients' overall survival. SII is calculated as follows: SII = platelet count × neutrophil/lymphocyte count. Higher SII scores have been correlated with worse outcome.

  6. Prognostic Nutritional Index (PNI)

    Time frame: Preoperatively

    Prognostic Nutritional Index (PNI) is a prognostic index that predicts patients' overall survival. PNI is calculated as follows: PNI = 10 × serum albumin value (g/dL) + 0.005 × total lymphocyte count (per mm3) in the peripheral blood. Higher PNI scores have been correlated with worse outcome.

  7. Surgical Stress Response - IL-6 - preoperatively

    Time frame: Preoperatively (as a baseline)

    Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups

  8. Surgical Stress Response - IL-6 - end of surgery

    Time frame: End of surgery (end of placement of last suture/ surgical clip on patient)

    Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups

  9. Surgical Stress Response - IL-6 - 24 hours after the end of surgery

    Time frame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)

    Inflammatory response and stress response as quantified by IL-6 serum levels. Blood sample collection will take place in both study groups

  10. Surgical Stress Response - IL-8 - preoperatively

    Time frame: Preoperatively (as a baseline)

    Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups

  11. Surgical Stress Response - IL-8 - end of surgery

    Time frame: End of surgery (end of placement of last suture/ surgical clip on patient)

    Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups

  12. Surgical Stress Response - IL-8 - 24 hours after the end of surgery

    Time frame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)

    Inflammatory response and stress response as quantified by IL-8 serum levels. Blood sample collection will take place in both study groups

  13. Surgical Stress Response - IL-10 - preoperatively

    Time frame: Preoperatively (as a baseline)

    Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups

  14. Surgical Stress Response - IL-10 - end of surgery

    Time frame: End of surgery (end of placement of last suture/ surgical clip on patient)

    Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups

  15. Surgical Stress Response - IL-10 - 24 hours after the end of surgery

    Time frame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)

    Inflammatory response and stress response as quantified by IL-10 serum levels. Blood sample collection will take place in both study groups

  16. Surgical Stress Response - TNF-a - preoperatively

    Time frame: Preoperatively (as a baseline)

    Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups

  17. Surgical Stress Response - TNF-a - end of surgery

    Time frame: End of surgery (end of placement of last suture/ surgical clip on patient)

    Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups

  18. Surgical Stress Response - TNF-a - 24 hours after the end of surgery

    Time frame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)

    Inflammatory response and stress response as quantified by TNF-a serum levels. Blood sample collection will take place in both study groups

  19. Surgical Stress Response - CRP - preoperatively

    Time frame: Preoperatively (as a baseline)

    Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups

  20. Surgical Stress Response - CRP - end of surgery

    Time frame: End of surgery (end of placement of last suture/ surgical clip on patient)

    Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups

  21. Surgical Stress Response - CRP - 24 hours after the end of surgery

    Time frame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)

    Inflammatory response and stress response as quantified by CRP serum levels. Blood sample collection will take place in both study groups

  22. Surgical Stress Response - WBC - preoperatively

    Time frame: Preoperatively (as a baseline)

    Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups

  23. Surgical Stress Response - WBC - end of surgery

    Time frame: End of surgery (end of placement of last suture/ surgical clip on patient)

    Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups

  24. Surgical Stress Response - WBC - 24 hours after the end of surgery

    Time frame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)

    Inflammatory response and stress response as quantified by WBC count. Blood sample collection will take place in both study groups

  25. Surgical Stress Response - AVP - preoperatively

    Time frame: Preoperatively (as a baseline)

    Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups

  26. Surgical Stress Response - AVP - end of surgery

    Time frame: End of surgery (end of placement of last suture/ surgical clip on patient)

    Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups

  27. Surgical Stress Response - AVP - 24 hours after the end of surgery

    Time frame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)

    Inflammatory response and stress response as quantified by AVP serum levels. Blood sample collection will take place in both study groups

  28. Surgical Stress Response - cortisol - preoperatively

    Time frame: Preoperatively (as a baseline)

    Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups

  29. Surgical Stress Response - cortisol - end of surgery

    Time frame: End of surgery (end of placement of last suture/ surgical clip on patient)

    Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups

  30. Surgical Stress Response - cortisol - 24 hours after the end of surgery

    Time frame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)

    Inflammatory response and stress response as quantified by cortisol serum levels. Blood sample collection will take place in both study groups

  31. Surgical Stress Response - HIF-1α- preoperatively

    Time frame: Preoperatively (as a baseline)

    Inflammatory response and stress response as quantified by HIF-1α serum levels. Blood sample collection will take place in both study groups

  32. Surgical Stress Response - HIF-1α - end of surgery

    Time frame: End of surgery (end of placement of last suture/ surgical clip on patient)

    Inflammatory response and stress response as quantified by HIF-1α serum levels. Blood sample collection will take place in both study groups

  33. Surgical Stress Response - HIF-1α - 24 hours after the end of surgery

    Time frame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)

    Inflammatory response and stress response as quantified by HIF-1α serum levels. Blood sample collection will take place in both study groups

  34. Surgical Stress Response - VEGF- preoperatively

    Time frame: Preoperatively (as a baseline)

    Inflammatory response and stress response as quantified by VEGF serum levels. Blood sample collection will take place in both study groups

  35. Surgical Stress Response - VEGF- end of surgery

    Time frame: End of surgery (end of placement of last suture/ surgical clip on patient)

    Inflammatory response and stress response as quantified by VEGF serum levels. Blood sample collection will take place in both study groups

  36. Surgical Stress Response - VEGF - 24 hours after the end of surgery

    Time frame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)

    Inflammatory response and stress response as quantified by VEGF serum levels. Blood sample collection will take place in both study groups

  37. Surgical Stress Response - NF-κB - preoperatively

    Time frame: Preoperatively (as a baseline)

    Inflammatory response and stress response as quantified by NF-κB serum levels. Blood sample collection will take place in both study groups

  38. Surgical Stress Response - NF-κB - end of surgery

    Time frame: End of surgery (end of placement of last suture/ surgical clip on patient)

    Inflammatory response and stress response as quantified by NF-κB serum levels. Blood sample collection will take place in both study groups

  39. Surgical Stress Response - NF-κB - 24 hours after the end of surgery

    Time frame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)

    Inflammatory response and stress response as quantified by NF-κB serum levels. Blood sample collection will take place in both study groups

  40. Haemodynamic Stability - Mean PR

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean PR will be reported for each patient, extracted from the collected data.

  41. Haemodynamic Stability - Minimum PR

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum PR will be reported for each patient, extracted from the collected data.

  42. Haemodynamic Stability - Maximum PR

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum PR will be reported for each patient, extracted from the collected data.

  43. Haemodynamic Stability - Standard Deviation PR

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation PR will be reported for each patient, extracted from the collected data.

  44. Haemodynamic Stability - PR Change Induction

    Time frame: 1 minute after anesthesia induction, compared to 1 minute prior

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate change 1 minute after anesthesia induction, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.

  45. Haemodynamic Stability - PR Change Incision

    Time frame: 1 minute after surgical incision, compared to 1 minute prior

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate change 1 minute after surgical incision, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.

  46. Haemodynamic Stability - Mean SBP

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean SBP will be reported for each patient, extracted from the collected data.

  47. Haemodynamic Stability - Minimum SBP

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum SBP will be reported for each patient, extracted from the collected data.

  48. Haemodynamic Stability - Maximum SBP

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum SBP will be reported for each patient, extracted from the collected data.

  49. Haemodynamic Stability - Standard Deviation SBP

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation SBP will be reported for each patient, extracted from the collected data.

  50. Haemodynamic Stability - SBP Change Induction

    Time frame: 1 minute after anesthesia induction, compared to 1 minute prior

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure change 1 minute after anesthesia induction, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.

  51. Haemodynamic Stability - SBP Change Incision

    Time frame: 1 minute after surgical incision, compared to 1 minute prior

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure change 1 minute after surgical incision, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.

  52. Haemodynamic Stability - Mean DBP

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean DBP will be reported for each patient, extracted from the collected data.

  53. Haemodynamic Stability - Minimum DBP

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum DBP will be reported for each patient, extracted from the collected data.

  54. Haemodynamic Stability - Maximum DBP

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum DBP will be reported for each patient, extracted from the collected data.

  55. Haemodynamic Stability - Standard Deviation DBP

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation DBP will be reported for each patient, extracted from the collected data.

  56. Haemodynamic Stability - DBP change induction

    Time frame: 1 minute after anesthesia induction, compared to 1 minute prior

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure change 1 minute after anesthesia induction, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.

  57. Haemodynamic Stability - DBP change incision

    Time frame: 1 minute after surgical incision, compared to 1 minute prior

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure change 1 minute after surgical incision, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.

  58. Haemodynamic Stability - Mean MBP

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean MBP will be reported for each patient, extracted from the collected data.

  59. Haemodynamic Stability - Minimum MBP

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum MBP will be reported for each patient, extracted from the collected data.

  60. Haemodynamic Stability - Maximum MBP

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum MBP will be reported for each patient, extracted from the collected data.

  61. Haemodynamic Stability - Standard Deviation MBP

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation MBP will be reported for each patient, extracted from the collected data.

  62. Haemodynamic Stability - MBP change induction

    Time frame: 1 minute after anesthesia induction, compared to 1 minute prior

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure change 1 minute after anesthesia induction, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.

  63. Haemodynamic Stability - MBP change incision

    Time frame: 1 minute after surgical incision, compared to 1 minute prior

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure change 1 minute after surgical incision, compared to 1 minute prior. Data will be collected from a pulse contour analysis monitor.

  64. Haemodynamic Stability - Mean CO

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean CO will be reported for each patient, extracted from the collected data.

  65. Haemodynamic Stability - Minimum CO

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum CO will be reported for each patient, extracted from the collected data.

  66. Haemodynamic Stability - Maximum CO

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum CO will be reported for each patient, extracted from the collected data.

  67. Haemodynamic Stability - Standard Deviation CO

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation CO will be reported for each patient, extracted from the collected data.

  68. Haemodynamic Stability - Mean CI

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean CI will be reported for each patient, extracted from the collected data.

  69. Haemodynamic Stability - Minimum CI

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum CI will be reported for each patient, extracted from the collected data.

  70. Haemodynamic Stability - Maximum CI

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum CI will be reported for each patient, extracted from the collected data.

  71. Haemodynamic Stability - Standard Deviation CI

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation CI will be reported for each patient, extracted from the collected data.

  72. Haemodynamic Stability - Mean SV

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean SV will be reported for each patient, extracted from the collected data.

  73. Haemodynamic Stability - Minimum SV

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum SV will be reported for each patient, extracted from the collected data.

  74. Haemodynamic Stability - Maximum SV

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum SV will be reported for each patient, extracted from the collected data.

  75. Haemodynamic Stability - Standard Deviation SV

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation SV will be reported for each patient, extracted from the collected data.

  76. Haemodynamic Stability - Mean SVV

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean SVV will be reported for each patient, extracted from the collected data.

  77. Haemodynamic Stability - Minimum SVV

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum SVV will be reported for each patient, extracted from the collected data.

  78. Haemodynamic Stability - Maximum SVV

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum SVV will be reported for each patient, extracted from the collected data.

  79. Haemodynamic Stability - Standard Deviation SVV

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation SVV will be reported for each patient, extracted from the collected data.

  80. Haemodynamic Stability - Mean SVI

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index - SVI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Mean SVI will be reported for each patient, extracted from the collected data.

  81. Haemodynamic Stability - Minimum SVI

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index - SVI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Minimum SVI will be reported for each patient, extracted from the collected data.

  82. Haemodynamic Stability - Maximum SVI

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index - SVI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Maximum SVI will be reported for each patient, extracted from the collected data.

  83. Haemodynamic Stability - Standard Deviation SVI

    Time frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index - SVI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds. Standard Deviation SVI will be reported for each patient, extracted from the collected data.

  84. Haemodynamic Stability - Tachycardia

    Time frame: Intraoperatively, assessed up to 4 hours.

    Intraoperative Tachycardia (defined as PR≥ 100 bpm), with episodes lasting ≥1 minute. Data will be reported in total seconds of intraoperative tachycardia.

  85. Haemodynamic Stability - Bradycardia

    Time frame: Intraoperatively, assessed up to 4 hours.

    Intraoperative Bradycardia (defined as PR≤ 60 bpm), with episodes lasting ≥1 minute. Data will be reported in total seconds of intraoperative bradycardia.

  86. Haemodynamic Stability - Hypotension

    Time frame: Intraoperatively, assessed up to 6 hours.

    Intraoperative Hypotension (defined as SBP≤100mmHg or ≤70% of preoperative Baseline), with episodes lasting ≥1 minute. All patients will have a 5 minute preoperative SBP baseline, with measurements every 20 seconds. Intraoperative data will be compared to the mean preoperative 5 minute SPB baseline. Data will be reported in total seconds of intraoperative hypotension.

  87. Haemodynamic Stability - Hypertension

    Time frame: Intraoperatively, assessed up to 6 hours.

    Intraoperative Hypertension (defined as SBP ≥130% of preoperative Baseline), with episodes lasting ≥1 minute. All patients will have a 5 minute preoperative SBP baseline, with measurements every 20 seconds. Intraoperative data will be compared to the mean preoperative 5 minute SPB baseline. Data will be reported in total seconds of intraoperative hypertension.

  88. Haemodynamic Stability - Fluid requirements - Crystalloids - Intraoperatively

    Time frame: Intraoperatively, assessed up to 6 hours.

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Crystalloid Fluid Requirements.

  89. Haemodynamic Stability - Fluid requirements - Colloids - Intraoperatively

    Time frame: Intraoperatively, assessed up to 6 hours.

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Colloid Fluid Requirements.

  90. Haemodynamic Stability - Fluid requirements - Concentrated RBCs - Intraoperatively

    Time frame: Intraoperatively, assessed up to 6 hours.

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Concentrated Red Blood Cell unit Requirements.

  91. Haemodynamic Stability - Fluid requirements - Plasma - Intraoperatively

    Time frame: Intraoperatively, assessed up to 6 hours.

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Plasma unit Requirements.

  92. Haemodynamic Stability - Fluid requirements - Platelets - Intraoperatively

    Time frame: Intraoperatively, assessed up to 6 hours.

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Platelet unit Requirements.

  93. Haemodynamic Stability - Blood Loss - Intraoperatively

    Time frame: Intraoperatively, assessed up to 6 hours.

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Blood Loss

  94. Haemodynamic Stability - Fluid Balance - Intraoperatively

    Time frame: Intraoperatively, assessed up to 6 hours.

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Fluid Balance

  95. Haemodynamic Stability - Vasoactive Requirements - Adrenaline - Intraoperatively

    Time frame: Intraoperatively, assessed up to 6 hours.

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Adrenaline requirements

  96. Haemodynamic Stability - Vasoactive Requirements - Noradrenaline - Intraoperatively

    Time frame: Intraoperatively, assessed up to 6 hours.

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Noradrenaline requirements

  97. Haemodynamic Stability - Vasoactive Requirements - Ephedrine - Intraoperatively

    Time frame: Intraoperatively, assessed up to 6 hours.

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Ephedrine requirements

  98. Haemodynamic Stability - Vasoactive Requirements - Phenylephrine - Intraoperatively

    Time frame: Intraoperatively, assessed up to 6 hours.

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Phenylephrine requirements

  99. Haemodynamic Stability - Vasoactive Requirements - Dopamine - Intraoperatively

    Time frame: Intraoperatively, assessed up to 6 hours.

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Dopamine requirements

  100. Haemodynamic Stability - Vasoactive Requirements - Dobutamine - Intraoperatively

    Time frame: Intraoperatively, assessed up to 6 hours.

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Dobutamine requirements

  101. Haemodynamic Stability - Vasoactive Requirements - Nitroglycerine - Intraoperatively

    Time frame: Intraoperatively, assessed up to 6 hours.

    Haemodynamic Stability as quantified by hemodynamic markers, specifically Nitroglycerine requirements

Secondary outcomes

  1. Acute postoperative pain - Numerical Rating Scale (NRS) - Immediately Postoperatively

    Time frame: Immediately postoperatively

    Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

  2. Acute postoperative pain - Numerical Rating Scale (NRS) - First postoperative day

    Time frame: First postoperative day

    Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

  3. Acute postoperative pain - Numerical Rating Scale (NRS) - Second postoperative day

    Time frame: Second postoperative day

    Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

  4. Acute postoperative pain - Numerical Rating Scale (NRS) - Third postoperative day

    Time frame: Third postoperative day

    Evaluation of patients' pain using scales: Numerical Rating Scale (NRS). The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

  5. Acute postoperative pain - Critical Care Pain Observation Tool (CPOT) - Immediately Postoperatively

    Time frame: Immediately postoperatively

    Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).

  6. Acute postoperative pain - Critical Care Pain Observation Tool (CPOT) - First postoperative day

    Time frame: First postoperative day

    Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).

  7. Acute postoperative pain - Critical Care Pain Observation Tool (CPOT) - Second postoperative day

    Time frame: Second postoperative day

    Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).

  8. Acute postoperative pain - Critical Care Pain Observation Tool (CPOT) - Third postoperative day

    Time frame: Third postoperative day

    Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT). The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients. Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).

  9. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - First postoperative day

    Time frame: First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    • Intolerable
    • Tolerable with discomfort
    • Comfortably manageable
    • Negligible Pain

    The percentage of patients that report pain that is "Intolerable" will be reported

  10. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - Second postoperative day

    Time frame: Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    • Intolerable
    • Tolerable with discomfort
    • Comfortably manageable
    • Negligible Pain

    The percentage of patients that report pain that is "Intolerable" will be reported

  11. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - Third postoperative day

    Time frame: Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    • Intolerable
    • Tolerable with discomfort
    • Comfortably manageable
    • Negligible Pain

    The percentage of patients that report pain that is "Intolerable" will be reported

  12. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - First postoperative day

    Time frame: First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    • Intolerable
    • Tolerable with discomfort
    • Comfortably manageable
    • Negligible Pain

    The percentage of patients that report pain that is "Tolerable with Discomfort" will be reported

  13. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - Second postoperative day

    Time frame: Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    • Intolerable
    • Tolerable with discomfort
    • Comfortably manageable
    • Negligible Pain

    The percentage of patients that report pain that is "Tolerable with Discomfort" will be reported

  14. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - Third postoperative day

    Time frame: Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    • Intolerable
    • Tolerable with discomfort
    • Comfortably manageable
    • Negligible Pain

    The percentage of patients that report pain that is "Tolerable with Discomfort" will be reported

  15. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - First postoperative day

    Time frame: First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    • Intolerable
    • Tolerable with discomfort
    • Comfortably manageable
    • Negligible Pain

    The percentage of patients that report pain that is "Comfortably manageable" will be reported

  16. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - Second postoperative day

    Time frame: Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    • Intolerable
    • Tolerable with discomfort
    • Comfortably manageable
    • Negligible Pain

    The percentage of patients that report pain that is "Comfortably manageable" will be reported

  17. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - Third postoperative day

    Time frame: Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    • Intolerable
    • Tolerable with discomfort
    • Comfortably manageable
    • Negligible Pain

    The percentage of patients that report pain that is "Comfortably manageable" will be reported

  18. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - First postoperative day

    Time frame: First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    • Intolerable
    • Tolerable with discomfort
    • Comfortably manageable
    • Negligible Pain

    The percentage of patients that report pain that is "Negligible Pain" will be reported

  19. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - Second postoperative day

    Time frame: Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    • Intolerable
    • Tolerable with discomfort
    • Comfortably manageable
    • Negligible Pain

    The percentage of patients that report pain that is "Negligible Pain" will be reported

  20. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - Third postoperative day

    Time frame: Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:

    • Intolerable
    • Tolerable with discomfort
    • Comfortably manageable
    • Negligible Pain

    The percentage of patients that report pain that is "Negligible Pain" will be reported

  21. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - First postoperative day

    Time frame: First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    • Getting worse
    • About the same
    • Getting better

    The percentage of patients that report pain that is "Getting worse" will be reported

  22. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - Second postoperative day

    Time frame: Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    • Getting worse
    • About the same
    • Getting better

    The percentage of patients that report pain that is "Getting worse" will be reported

  23. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - Third postoperative day

    Time frame: Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    • Getting worse
    • About the same
    • Getting better

    The percentage of patients that report pain that is "Getting worse" will be reported

  24. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - First postoperative day

    Time frame: First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    • Getting worse
    • About the same
    • Getting better

    The percentage of patients that report pain that is "About the same" will be reported

  25. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - Second postoperative day

    Time frame: Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    • Getting worse
    • About the same
    • Getting better

    The percentage of patients that report pain that is "About the same" will be reported

  26. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - Third postoperative day

    Time frame: Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    • Getting worse
    • About the same
    • Getting better

    The percentage of patients that report pain that is "About the same" will be reported

  27. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - First postoperative day

    Time frame: First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    • Getting worse
    • About the same
    • Getting better

    The percentage of patients that report pain that is "Getting Better" will be reported

  28. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - Second postoperative day

    Time frame: Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    • Getting worse
    • About the same
    • Getting better

    The percentage of patients that report pain that is "Getting Better" will be reported

  29. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - Third postoperative day

    Time frame: Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:

    • Getting worse
    • About the same
    • Getting better

    The percentage of patients that report pain that is "Getting Better" will be reported

  30. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - First postoperative day

    Time frame: First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    • Inadequate pain control
    • Effective, just about right
    • Would like to reduce medication

    The percentage of patients that report "Inadequate pain control" will be reported

  31. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - Second postoperative day

    Time frame: Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    • Inadequate pain control
    • Effective, just about right
    • Would like to reduce medication

    The percentage of patients that report "Inadequate pain control" will be reported

  32. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - Third postoperative day

    Time frame: Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    • Inadequate pain control
    • Effective, just about right
    • Would like to reduce medication

    The percentage of patients that report "Inadequate pain control" will be reported

  33. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - First postoperative day

    Time frame: First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    • Inadequate pain control
    • Effective, just about right
    • Would like to reduce medication

    The percentage of patients that report "Effective, just about right" will be reported

  34. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - Second postoperative day

    Time frame: Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    • Inadequate pain control
    • Effective, just about right
    • Would like to reduce medication

    The percentage of patients that report "Effective, just about right" will be reported

  35. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - Third postoperative day

    Time frame: Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    • Inadequate pain control
    • Effective, just about right
    • Would like to reduce medication

    The percentage of patients that report "Effective, just about right" will be reported

  36. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - First postoperative day

    Time frame: First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    • Inadequate pain control
    • Effective, just about right
    • Would like to reduce medication

    The percentage of patients that report "Would like to reduce medication" will be reported

  37. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - Second postoperative day

    Time frame: Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    • Inadequate pain control
    • Effective, just about right
    • Would like to reduce medication

    The percentage of patients that report "Would like to reduce medication" will be reported

  38. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - Third postoperative day

    Time frame: Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:

    • Inadequate pain control
    • Effective, just about right
    • Would like to reduce medication

    The percentage of patients that report "Would like to reduce medication" will be reported

  39. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - First postoperative day

    Time frame: First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    • Can't do anything because of pain
    • Pain keeps me from doing most of what I need to do
    • Can do most things, but pain gets in the way of some
    • Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can't do anything because of pain" will be reported

  40. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - Second postoperative day

    Time frame: Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    • Can't do anything because of pain
    • Pain keeps me from doing most of what I need to do
    • Can do most things, but pain gets in the way of some
    • Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can't do anything because of pain" will be reported

  41. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - Third postoperative day

    Time frame: Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    • Can't do anything because of pain
    • Pain keeps me from doing most of what I need to do
    • Can do most things, but pain gets in the way of some
    • Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can't do anything because of pain" will be reported

  42. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - First postoperative day

    Time frame: First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    • Can't do anything because of pain
    • Pain keeps me from doing most of what I need to do
    • Can do most things, but pain gets in the way of some
    • Can do everything I need to do

    The percentage of patients whose functioning is reported as "Pain keeps me from doing most of what I need to do" will be reported

  43. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - Second postoperative day

    Time frame: Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    • Can't do anything because of pain
    • Pain keeps me from doing most of what I need to do
    • Can do most things, but pain gets in the way of some
    • Can do everything I need to do

    The percentage of patients whose functioning is reported as "Pain keeps me from doing most of what I need to do" will be reported

  44. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - Third postoperative day

    Time frame: Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    • Can't do anything because of pain
    • Pain keeps me from doing most of what I need to do
    • Can do most things, but pain gets in the way of some
    • Can do everything I need to do

    The percentage of patients whose functioning is reported as "Pain keeps me from doing most of what I need to do" will be reported

  45. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - First postoperative day

    Time frame: First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    • Can't do anything because of pain
    • Pain keeps me from doing most of what I need to do
    • Can do most things, but pain gets in the way of some
    • Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can do most things, but pain gets in the way of some" will be reported

  46. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - Second postoperative day

    Time frame: Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    • Can't do anything because of pain
    • Pain keeps me from doing most of what I need to do
    • Can do most things, but pain gets in the way of some
    • Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can do most things, but pain gets in the way of some" will be reported

  47. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - Third postoperative day

    Time frame: Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    • Can't do anything because of pain
    • Pain keeps me from doing most of what I need to do
    • Can do most things, but pain gets in the way of some
    • Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can do most things, but pain gets in the way of some" will be reported

  48. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - First postoperative day

    Time frame: First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    • Can't do anything because of pain
    • Pain keeps me from doing most of what I need to do
    • Can do most things, but pain gets in the way of some
    • Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can do everything I need to do" will be reported

  49. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - Second postoperative day

    Time frame: Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    • Can't do anything because of pain
    • Pain keeps me from doing most of what I need to do
    • Can do most things, but pain gets in the way of some
    • Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can do everything I need to do" will be reported

  50. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - Third postoperative day

    Time frame: Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:

    • Can't do anything because of pain
    • Pain keeps me from doing most of what I need to do
    • Can do most things, but pain gets in the way of some
    • Can do everything I need to do

    The percentage of patients whose functioning is reported as "Can do everything I need to do" will be reported

  51. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - First postoperative day

    Time frame: First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    • Awake with pain most of the night
    • Awake with occasional pain
    • Normal sleep

    The percentage of patients whose sleep is reported as "Awake with pain most of the night" will be reported

  52. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - Second postoperative day

    Time frame: Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    • Awake with pain most of the night
    • Awake with occasional pain
    • Normal sleep

    The percentage of patients whose sleep is reported as "Awake with pain most of the night" will be reported

  53. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - Third postoperative day

    Time frame: Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    • Awake with pain most of the night
    • Awake with occasional pain
    • Normal sleep

    The percentage of patients whose sleep is reported as "Awake with pain most of the night" will be reported

  54. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - First postoperative day

    Time frame: First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    • Awake with pain most of the night
    • Awake with occasional pain
    • Normal sleep

    The percentage of patients whose sleep is reported as " Awake with occasional pain" will be reported

  55. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - Second postoperative day

    Time frame: Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    • Awake with pain most of the night
    • Awake with occasional pain
    • Normal sleep

    The percentage of patients whose sleep is reported as " Awake with occasional pain" will be reported

  56. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - Third postoperative day

    Time frame: Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    • Awake with pain most of the night
    • Awake with occasional pain
    • Normal sleep

    The percentage of patients whose sleep is reported as " Awake with occasional pain" will be reported

  57. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - First postoperative day

    Time frame: First postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    • Awake with pain most of the night
    • Awake with occasional pain
    • Normal sleep

    The percentage of patients whose sleep is reported as "Normal sleep" will be reported

  58. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - Second postoperative day

    Time frame: Second postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    • Awake with pain most of the night
    • Awake with occasional pain
    • Normal sleep

    The percentage of patients whose sleep is reported as "Normal sleep" will be reported

  59. Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - Third postoperative day

    Time frame: Third postoperative day

    Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:

    • Awake with pain most of the night
    • Awake with occasional pain
    • Normal sleep

    The percentage of patients whose sleep is reported as "Normal sleep" will be reported

  60. Analgesic Requirements - First postoperative day

    Time frame: First postoperative day

    Evaluation of patients' pain by recording the number of times that rescue analgesia (tramadol) was required.

  61. Analgesic Requirements - Second postoperative day

    Time frame: Second postoperative day

    Evaluation of patients' pain by recording the number of times that rescue analgesia (tramadol) was required.

  62. Analgesic Requirements - Third postoperative day

    Time frame: Third postoperative day

    Evaluation of patients' pain by recording the number of times that rescue analgesia (tramadol) was required.

  63. Postoperative Pulmonary Complications - Aspiration Pneumonitis

    Time frame: From the first postoperative day, until the fifth postoperative day

    Aspiration pneumonitis (defined as respiratory failure after the inhalation of regurgitated gastric contents)

  64. Postoperative Pulmonary Complications - Moderate respiratory failure

    Time frame: From the first postoperative day, until the fifth postoperative day

    Moderate respiratory failure (SpO2 < 90% or PaO2 < 60 mmHg for 10 min in room air, responding to oxygen > 2 L/min)

  65. Postoperative Pulmonary Complications - Severe respiratory failure

    Time frame: From the first postoperative day, until the fifth postoperative day

    Severe respiratory failure (need for non-invasive or invasive mechanical ventilation due to poor oxygenation)

  66. Postoperative Pulmonary Complications - ARDS

    Time frame: From the first postoperative day, until the fifth postoperative day

    Adult respiratory distress syndrome (mild, moderate, or severe according to the Berlin definition)

  67. Postoperative Pulmonary Complications - Pulmonary Infection

    Time frame: From the first postoperative day, until the fifth postoperative day

    Pulmonary infection (defined as new or progressive radiographic infiltrate plus at least two of the following: antibiotic treatment, tympanic temperature > 38 °C, leukocytosis or leucopenia (white blood cell (WBC) count < 4000 cells/mm3 or > 12,000 cells/mm3) and/or purulent secretions)

  68. Postoperative Pulmonary Complications - Atelectasis

    Time frame: From the first postoperative day, until the fifth postoperative day

    Atelectasis (suggested by lung opacification with shift of the mediastinum, hilum, or hemidiaphragm towards the affected area, and compensatory over-inflation in the adjacent non-atelectatic lung)

  69. Postoperative Pulmonary Complications - Cardiopulmonary edema

    Time frame: From the first postoperative day, until the fifth postoperative day

    Cardiopulmonary edema (defined as clinical signs of congestion, including dyspnea, edema, rales, and jugular venous distention, with the chest x-ray demonstrating increase in vascular markings and diffuse alveolar interstitial infiltrates)

  70. Postoperative Pulmonary Complications - Pleural effusion

    Time frame: From the first postoperative day, until the fifth postoperative day

    Pleural effusion (chest x-ray demonstrating blunting of the costophrenic angle, loss of the sharp silhouette of the ipsilateral hemidiaphragm in upright position, evidence of displacement of adjacent anatomical structures, or (in supine position) a hazy opacity in one hemithorax with preserved vascular shadows)

  71. Postoperative Pulmonary Complications - Pneumothorax

    Time frame: From the first postoperative day, until the fifth postoperative day

    Pneumothorax (defined as air in the pleural space with no vascular bed surrounding the visceral pleura)

  72. Postoperative Pulmonary Complications - Pulmonary Infiltrates

    Time frame: From the first postoperative day, until the fifth postoperative day

    Pulmonary infiltrates (chest x-ray demonstrating new monolateral or bilateral infiltrate without other clinical signs)

  73. Postoperative Pulmonary Complications - Prolonged air leakage

    Time frame: From the first postoperative day, until the fifth postoperative day

    Prolonged air leakage (air leak requiring at least 7 days of postoperative chest tube drainage)

  74. Postoperative Pulmonary Complications - Purulent pleuritic

    Time frame: From the first postoperative day, until the fifth postoperative day

    Purulent pleuritic (receiving antibiotics for a suspected infection, as far as not explained by the preoperative patient condition alone)

  75. Postoperative Pulmonary Complications - Pulmonary embolism

    Time frame: From the first postoperative day, until the fifth postoperative day

    Pulmonary embolism (as documented by pulmonary arteriogram or autopsy, or supported by ventilation/perfusion radioisotope scans, or documented by echocardiography and receiving specific therapy)

  76. Postoperative Pulmonary Complications - Lung hemorrhage

    Time frame: From the first postoperative day, until the fifth postoperative day

    Lung hemorrhage (bleeding through the chest tubes requiring reoperation, or three or more red blood cell packs)

  77. Chronic postoperative pain - Pain Detect

    Time frame: Three months after the end of surgery

    Evaluation of patients' pain using the standardized "Pain Detect" questionnaire. The "Pain Detect" questionnaire has been standardized for screening the presence of a neuropathic pain component. Patients will be interviewed by phone interview, 3 months after the end of surgery. The possible score a patient can have, ranges from 0 to 38.

Study contacts

Contact information is provided by the study sponsor or research team.

Georgios Stefanakis, MD, PhD

CONTACT

[email protected]

00306978779726

Periklis Vasilos, MD

CONTACT

[email protected]

00306978702023

Sponsors and collaborators

Lead sponsor

University of Crete

Other

Registry information

Official study title

Effect of a Perioperative Opioid Free Anaesthesia-Analgesia (OFA-A) Strategy on Surgical Stress Response and Immunomodulation in Elective VATS Lobectomy for NSCLC Lung Cancer: A Prospective Randomized Study

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Dec 29, 2021
Registry last updated
Dec 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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