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Completed

NCT Number: NCT02154763

The Use of Intraperitoneal Ropivacaine in Bariatric Bypass Surgery

This is a pilot study in a randomized, controlled, double-blinded format and will evaluate the ability of a local anesthetic, Ropivacaine, to decrease pain after gastric bypass surgery. The drug will be administered into the abdomen during a bariatric bypass surgery. After surgery, patients who received Ropivacaine will be compared to those without Ropivacaine to determine its effect on reducing pain, recovery of lung function, ability to walk, and quality of life during recovery.

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Key information

Conditions

Bariatric Surgery Candidate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

About this study

Introduction: Postoperative pain control remains a major challenge for surgical procedures, including laparoscopic gastric bypass. Pain management is particularly relevant in obese patients who experience a higher number of of cardiovascular and pulmonary events. effective pain management may reduce their risk of serious postoperative complications, such as deep venous thrombosis and pulmonary emboli. The objective of this study is to evaluate the efficacy of intraperitoneal local anaesthetic, ropivacaine, to reduce postoperative pain in patients undergoing laparoscopic Roux-en-Y gastric bypass.

Methods and Analysis: A randomized controlled trial will be conducted to compare intraperitoneal ropivacaine (Intervention) versus normal saline (placebo) in 120 adult patients undergoing bariatric surgery. Ropivacaine will be infused over the oesophageal hiatus and throughout the abdomen. Patients in the control arm will undergo the same treatment as normal saline. The primary end point will be postoperative pain at 1, 2 and 4 hours postoperatively. Pain measurements will then occur every 4 hours for 24 h and every 8h until discharge. Secondary endpoints will include opioid use, peak expiratory flow, 6 min walk distance and quality of life. Intention-to-treat analysis will be used and repeated measures will be analysed using mixed model approach. post-hoc pairwise comparison of the treatment groups at different time points will be carried out using multiple comparisons with adjustments to the type 1 error. Results of the study will inform the feasibility of effectiveness of intraperitoneal ropivacaine.

Ethics and dissemination This study has been approved by the Ottawa Health Science Network Research Ethics Board and Health Canada in April 2014. The findings of the study will be disseminated through national and international conferences and peer-reviewed journals.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing Roux-en-Y gastric bypass surgery;
  • Patients who able to tolerate general anesthetic and pneumoperitoneum;
  • Patients who able to provide informed consent for the surgery;
  • Patients over the age of 18 years;

Exclusion criteria

  • Patient undergoing planned Sleeve Gastrectomy (inta-op conversion to Sleeve Gastrectomy after delivery of intraperitoneal ropivacaine will be included and analyzed using intention-to-treat approach)
  • Patients with an allergy to local anesthetics
  • Patients with severe underlying cardiovascular disease (ie: congestive heart failure, conduction abnormalities, and ischemic heart disease)
  • Patients with chronic renal disease Stage 3 or greater (Creatinine clearance less than 60mL/hr (millilitre per hour))
  • Patients with hepatic dysfunction Child-Pugh Class B or C
  • Patients with previous foregut surgery including esophageal, gastric, liver, and pancreas resections

Treatment and study plan

Ropivacaine

Drug

Other names: NAROPIN®, 84057-95-4

normal saline

Drug

Other names: Sodium Chloride, 7647-14-5

Primary outcomes

  1. 0-1 h Postoperative Pain Level

    Time frame: 0-1 hours post operatively

    Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).

  2. 1-2 h Postoperative Pain Level

    Time frame: 1-2 hours post operatively

    Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).

  3. 2-4 Hours Post Operative Pain Level

    Time frame: 2-4 hours post operatively

    Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).

  4. 4-8 Hours Post Operative Pain Level

    Time frame: 4-8 hours post operatively

    Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).

  5. 8-12 Hours Post Operative Pain Level

    Time frame: 8-12 hours post operatively

    Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).

  6. 12-16 Hours Post Operative Pain Level

    Time frame: 12-16 hours post operatively

    Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).

  7. 16-20 Hours Post Operative Pain Level

    Time frame: 16-20 hours post operatively

    Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).

  8. 20-24 Hours Post Operative Pain Level

    Time frame: 20-24 hours post operatively

    Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).

  9. 24-32 Hours Post Operative Pain Level

    Time frame: 24-32 hours post operatively

    Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).

  10. 32-40 Hours Post Operative Pain Level

    Time frame: 32-40 hours post operatively

    Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).

  11. 40-48 Hours Post Operative Pain Level

    Time frame: 40-48 hours post operatively

    Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome).

Secondary outcomes

  1. 1h Peak Expiratory Flow (PEF) Score

    Time frame: 1 hours post operatively

    Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.

  2. 2h Peak Expiratory Flow (PEF) Score

    Time frame: 2 hours post operatively

    Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.

  3. 4h Peak Expiratory Flow (PEF) Score

    Time frame: 4 hours post operatively

    Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.

  4. 8h Peak Expiratory Flow (PEF) Score

    Time frame: 8 hours post operatively

    Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.

  5. 12h Peak Expiratory Flow (PEF) Score

    Time frame: 12 hours post operatively

    Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.

  6. 16h Peak Expiratory Flow (PEF) Score

    Time frame: 16 hours post operatively

    Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.

  7. 20h Peak Expiratory Flow (PEF) Score

    Time frame: 20 hours post operatively

    Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.

  8. 24h Peak Expiratory Flow (PEF) Score

    Time frame: 24 hours post operatively

    Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.

  9. 32h Peak Expiratory Flow (PEF) Score

    Time frame: 32 hours post operatively

    Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.

  10. 40h Peak Expiratory Flow (PEF) Score

    Time frame: 40 hours post operatively

    Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.

  11. 48h Peak Expiratory Flow (PEF) Score

    Time frame: 48 hours post operatively

    Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point.

  12. 6 Minute Walking Distance Post Operative Day 1 (POD1)

    Time frame: Post operative day 1

    6-Minute walk distance (6MWD)-Defined as the distance in (m) an individual is able to walk a long a flat 30 m walkway over six--minute period, with breaks as required. walk testing has been validated in the obese population, clinically significant differences occur when distances of at least 80m occur. 0 m would be the worst possible value for this outcome and the higher the number achieved in the six-minute duration the better (Better outcome)

  13. 6 Minute Walking Distance Post Operative Day 2 (POD2)

    Time frame: Post operative day 2

    6-Minute walk distance (6MWD)-Defined as the distance in (m) an individual is able to walk a long a flat 30 m walkway over six--minute period, with breaks as required. walk testing has been validated in the obese population, clinically significant differences occur when distances of at least 80m occur. 0 m would be the worst possible value for this outcome and the higher the number achieved in the six-minute duration the better (Better outcome)

  14. Postoperative Day 1 Quality of Recovery Questionnaire (QR-40)

    Time frame: Post operative day 1

    40-item questionnaire provides a global score(Minimum-score 40, Maximum-Score 200, Higher score represent better Quality of recovery of participant in both global and subscores) subscores(summed to total the global score) across five dimensions explained below, in all categories minimum score is 1, maximum score of 5 for each question.unit is scores on a scale for all questions.

    Emotional_State:9 questions subscore can range between 9-45 Physical_Comfort:12 questions, subscore range between 12-60 Psychological Support:7 questions, subscore range between 7-35 Physical_Independence:5 questions, subscore range between 5-25 Pain:7 questions, subscore range between 5-25

    Questionnaire has two parts A and B, In part A, a score of 1 represents the answer of "None of the time (Poor)"and 5 represents the answer"All of the time (Excellent)"Part B, score of 1 represents the answer"All of the time (Excellent)" and 5 represents"None of the time (Poor)

  15. 0-1 h Postoperative Tylenol Consumption

    Time frame: 0-1 hours post operatively

    The amount in mg of Tylenol administered to the patient

  16. 0-1 h Postoperative Ketorolac Consumption

    Time frame: 0-1 hours post operatively

    The amount in mg of Ketorolac administered to patient

  17. 0-1 h Postoperative Dilaudid Consumption

    Time frame: 0-1 hours post operatively

    The amount in mg of Dilaudid administered to patient

  18. 0-1 h Postoperative Tramadol Consumption

    Time frame: 0-1 h Postoperative Tramadol consumption

    The amount in mg of Tramadol administered to patient

  19. 0-1 h Postoperative Fentanyl Consumption

    Time frame: 0-1 hours post operatively

    The amount in mcg of Fentanyl administered to patient

  20. 1-2 h Postoperative Tylenol Consumption

    Time frame: 1-2 hours post operatively

    The amount in mg of Tylenol administered to patient

  21. 1-2 h Postoperative Ketorolac Consumption

    Time frame: 1-2 hours post operatively

    The amount in mg of Ketorolac administered to patient

  22. 1-2 h Postoperative Dilaudid Consumption

    Time frame: 1-2 hours post operatively

    The amount in mg of Dilaudid administered to patient

  23. 1-2 h Postoperative Tramadol Consumption

    Time frame: 1-2 hours post operatively

    The amount in mg of Tramadol administered to patient

  24. 1-2 h Postoperative Fentanyl Consumption

    Time frame: 1-2 hours post operatively

    The amount in mcg of Fentanyl administered to patient

  25. 2-4 h Postoperative Tylenol Consumption

    Time frame: 2-4 hours post operatively

    The amount in mg of Tylenol administered to patient

  26. 2-4 h Postoperative Ketorolac Consumption

    Time frame: 2-4 hours post operatively

    The amount in mg of Ketorolac administered to patient

  27. 2-4 h Postoperative Dilaudid Consumption

    Time frame: 2-4 hours post operatively

    The amount in mg of Dilaudid administered to patient

  28. 2-4 h Postoperative Tramadol Consumption

    Time frame: 2-4 hours post operatively

    The amount in mg of Tramadol administered to patient

  29. 2-4 h Postoperative Fentanyl Consumption

    Time frame: 2-4 hours post operatively

    The amount in mcg of Fentanyl administered to patient

  30. 4-12 h Postoperative Tylenol Consumption

    Time frame: 4-12 hours post operatively

    The amount in mg of Tylenol administered to patient

  31. 4-12 h Postoperative Ketorolac Consumption

    Time frame: 4-12 hours post operatively

    The amount in mg of Ketorolac administered to patient

  32. 4-12 h Postoperative Tramadol Consumption

    Time frame: 4-12 hours post operatively

    The amount in mg of Tramadol administered to patient

  33. 4-12 h Postoperative Dilaudid Consumption

    Time frame: 4-12 hours post operatively

    The amount in mg of Dilaudid administered to patient

  34. 12-24 h Postoperative Tylenol Consumption

    Time frame: 12-24 hours post operatively

    The amount in mg of Tylenol administered to patient

  35. 12-24 h Postoperative Ketorolac Consumption

    Time frame: 12-24 hours post operatively

    The amount in mg of Ketorolac administered to patient

  36. 12-24 h Postoperative Tramadol Consumption

    Time frame: 12-24 hours post operatively

    The amount in mg of Tramadol administered to patient

  37. 12-24 h Postoperative Dilaudid Consumption

    Time frame: 12-24 hours post operatively

    The amount in mg of Dilaudid administered to patient

  38. 24-48 h Postoperative Tylenol Consumption

    Time frame: 24-48 hours post operatively

    The amount in mg of Tylenol administered to patient

  39. 24-48 h Postoperative Ketorolac Consumption

    Time frame: 24-48 hours post operatively

    The amount in mg of Ketorolac administered to patient

  40. 24-48 h Postoperative Tramadol Consumption

    Time frame: 24-48 hours post operatively

    The amount in mg of Tramadol administered to patient

  41. 24-48 h Postoperative Dilaudid Consumption

    Time frame: 24-48 hours post operatively

    The amount in mg of Dilaudid administered to patient

  42. Postoperative Day 7-10 Quality of Recovery Questionnaire (QR-40)

    Time frame: Post operative day 7-10

    40-item questionnaire provides a global score(Minimum-score 40,Maximum-Score 200, Higher score represent better Quality of recovery of participant in both global and subscores) subscores(summed to total the global score) across five dimensions explained below, in all categories minimum score is 1,maximum score of 5 for each question.unit is scores on a scale for all questions.

    Emotional_State:9 questions subscore can range between 9-45 Physical_Comfort:12 questions, subscore range between 12-60 Psychological Support:7 questions, subscore range between 7-35 Physical_Independence:5 questions, subscore range between 5-25 Pain:7 questions,subscore range between 5-25

    Questionnaire has two parts A and B, In part A, a score of 1 represents the answer of "None of the time (Poor)"and 5 represents the answer"All of the time (Excellent)"Part B, score of 1 represents the answer"All of the time (Excellent)" and 5 represents"None of the time (Poor)

  43. 6 Minute Walking Distance Post Operative Day 7-10 (POD 7-10)

    Time frame: Post operative day 7-10 (Follow-up Clinic)

    6-Minute walk distance (6MWD)-Defined as the distance in (m) an individual is able to walk a long a flat 30 m walkway over six--minute period, with breaks as required. walk testing has been validated in the obese population, clinically significant differences occur when distances of at least 80m occur. 0 m would be the worst possible value for this outcome and the higher the number achieved in the six-minute duration the better (Better outcome)

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

A Pilot Study to Assess the Feasibility of a Future Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Role of Intra-Peritoneal Ropivacaine in Gastric Bypass Surgery: INOPAIN Trial

Acronym: INOPAIN

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 3, 2014
Registry last updated
Mar 19, 2019

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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