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Enrolling by Invitation

NCT Number: NCT05315596

Longitudinal Assessment of Pain-Related Patient-Reported Outcomes After Surgery

Little is known about pain-related outcomes experienced by patients in the first few weeks after surgery, once they are discharged from hospital.

This study aims to characterize pain, pain-related interference, and early neuropathic pain in the sub-acute phase after surgery.

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Key information

Conditions

Pain, Postoperative Adult Agnosia Analgesia Functional Status Nervous System Diseases Neuralgia Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Diseases Pain Pain Management Pain Measurement Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Peripheral Nervous System Diseases Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jena University Hospital, Jena, Germany

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About this study

A high proportion of patients experience moderate to severe pain after surgery. However, most of the knowledge about this comes from studies where patients are evaluated in the hours and up until the first postoperative day. Alternatively, patients are assessed several months (eg 3 or later) after surgery, to evaluate the development of chronic pain related to surgery (CPSP) and most patients do not develop CPSP.

This study aims to learn how patients recover concerning pain and function once they return home after surgery. How long is it before they can resume their daily activities and to do so in comfort? Do they take treatment for pain? Do they have pain restricted to the surgical incision or it is more widespread? There is little knowledge as to whether there are signs of nerve injury in the days close to surgery. This type of pain might lead to chronic pain in later stages.

Patients will be assessed at three time points: the first day after surgery, the 7th day after surgery, and 1 month.

The information we obtain will offer healthcare providers, from multiple hospitals, information about the care they provide to their patients for pain while patients are still in hospital and insights as to how the care might be improved, once they are discharged.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult
  • On the first post-operative day and back on the ward for at least 6 hours
  • Gives consent for assessment at 3-time points

Exclusion criteria

  • The patient is unable to communicate
  • The patient is cognitively impaired
  • The patient is asleep
  • The patient is too ill or in too much pain and does not wish to be interviewed
  • The patient does not wish to fill in the outcomes questionnaire

Treatment and study plan

Primary outcomes

  1. The difference in pain interference scores between postoperative day 7 (POD7) and 1 month after surgery (POM1).

    Time frame: 7th day after surgery (POD7) and 1 Month (M1) after surgery

    We will assess whether pain-related functional impairment on postoperative day 7 is associated with functional pain-related impairment 1 month after surgery. Functional pain impairment will be assessed using the BPI short-form questionnaire and calculated as a Pain Interference Total Score (PITS) from the 7 interference questions in the BPI. Patients will be allocated to groups of no (PITS=0)/mild-(PITS=1-2)/ moderate /(PITS=2-5) and severe interference (PITS>5). Mean scores of the 2 domains within the functional items, physical interference (general activity, walking ability, and work) and effective interference (mood, enjoyment of life, and relations with other persons) will also be calculated. Sleep will addressed separately as it does not improve psychometric properties of the BPI interference scale. This methodology has been used in another PAIN OUT study, evaluating function at 6 months after surgery (Stamer et al, Pain. 2019 Aug;160(8):1856-1865).

  2. The number of patients with high pain interference on the 7th day after surgery (POD7).

    Time frame: Day 7 after surgery

    Number of patients with high pain interference at postoperative day 7 (POD7, BPI-PITS >5).

Secondary outcomes

  1. Differences in pain severity (BPI-PSVS, pain severity scale) between postoperative day 7 and 1 month after surgery (POM1).

    Time frame: Day 7 after surgery and Month 1 after surgery

    We will use the pain severity variables in the BPI to assess pain on postoperative day 7 compared to Month 1 after surgery.

  2. The differences in pain interference (BPI-PITS) between surgical disciplines on postoperative day 7.

    Time frame: Day 7 after surgery

    This will be a cohort of patients undergoing surgeries from different disciplines. We anticipate that median pain interference scores will not differ between the disciplines.

  3. The differences in pain interference (BPI-PITS) between surgical disciplines at month 1 after surgery.

    Time frame: 1 Month after surgery

    This will be a cohort of patients undergoing surgeries from different disciplines. We anticipate that median pain interference scores will not differ between the disciplines.

  4. The difference in the number of patients with signs of neuropathy on postoperative day 7 between the surgical disciplines.

    Time frame: Day 7 after surgery

    The difference in the number of patients with signs of neuropathy on postoperative day 7 (DN2 score ≥ 3/7) between the surgical disciplines.

    Neuropathy will be screened for using the 'Douleur Neuropathique en 2 Questions' (DN2) . Neuropathy is indicated for a score of >3/7 items in the questionnaire (Beloeil et al Early postoperative neuropathic pain assessed by the DN4 score predicts an increased risk of persistent postsurgical neuropathic pain. Eur J Anesthesiology 2017;34:652-7).

  5. The difference in the number of patients with signs of neuropathy at 1 month after surgery (POM1) between the surgical disciplines.

    Time frame: 1 Month after surgery

    The difference in the number of patients with signs of neuropathy at POM1 (DN2 score ≥ 3/7) between the surgical disciplines.

  6. Differences in pain interference scores between patients with vs without signs of neuropathy on postoperative day 7

    Time frame: Day 7 after surgery

    Differences in pain interference (BPI-PITS) between patients with vs. without signs of neuropathy (DN2 score ≥ 3/7) on postoperative day 7.

  7. Differences in pain interference (BPI-PITS) between patients with vs. without signs of neuropathy (DN2 score ≥ 3/7) at POM1.

    Time frame: 1 Month after surgery

    Differences in pain interference (BPI-PITS) between patients with vs. without signs of neuropathy (DN2 score ≥ 3/7) at POM1.

  8. Differences in pain severity between patients with vs without signs of neuropathy at POM1

    Time frame: 1 Month after surgery

    Differences in pain severity (BPI-PSVS) between patients with vs. without signs of neuropathy (DN2 score ≥ 3/7) at POM1.

  9. Assess the difference in the number of patients taking analgesics o POD7 vs POD1.

    Time frame: Day 7 after surgery and 1 Month after surgery

    The difference in the number of patients taking analgesics between postoperative day 7 and POM1. Patients will be asked if they are taking an analgesic at both time points.

Other outcomes

  1. Exploratory regression analysis for improving understanding of pain interference on day 7 after surgery

    Time frame: First postoperative day and postoperative day 7

    Exploratory regression analysis for pain interference on postoperative day 7 (BPI-PITS, dependent variable), demographic variables, perioperative treatment variables and patient-reported outcomes (International Pain Out Questionnaire) from the first post-operative day (POD1).

  2. Exploratory regression analysis for improving understanding of pain intensity on postoperative day 7.

    Time frame: First postoperative day and postoperative day 7

    Exploratory regression analysis for pain intensity on postoperative day 7 (BPI-PSVS, dependent variable). Independent variables will include demographic variables, perioperative treatment variables and patient-reported outcomes obtained on the first postoperative day (POD1)

  3. Exploratory regression analysis for improving understanding of pain intensity at POM1

    Time frame: First postoperative day and 1 month after surgery

    Exploratory regression analysis for pain intensity at POM1 (BPI-PSVS, dependent variable). Independent variables will include: demographic variables, perioperative treatment variables and patient reported outcomes (International Pain Out Questionnaire) from the first postoperative day (POD1).

Sponsors and collaborators

Lead sponsor

Jena University Hospital

Other

Collaborators

  • Centro Medico Nacional Siglo XXI IMSS
  • Fundación Clínica Médica Sur
  • Hospital Angeles Lomas
  • Hospital Angeles Puebla
  • Hospital Aranda de La Parra (Leon Guanajuato)
  • Hospital Central "Dr. Ignacio Morones Prieto"
  • Hospital Central Militar
  • Hospital General Dr. Ruben Leñero
  • Hospital General Regional Número 2 Dr. Guillermo Fajardo Ortiz
  • Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo
  • Hospital San Javier Guadalajara
  • Hospital de Traumatología y Ortopedia Lomas Verdes
  • Instituto Nacional de Cancerologia de Mexico
  • Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
  • Instituto Nacional de Enfermedades Respiratorias

Registry information

Official study title

Longitudinal Assessment of Pain-related Patient-reported Outcomes in the Sub-acute Phase After Surgery: a Registry Study From PAIN OUT

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Apr 7, 2022
Registry last updated
Apr 7, 2022

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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