Clinical trial NCT02154763: The Use of Intraperitoneal Ropivacaine in Bariatric Bypass Surgery
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bariatric Surgery Candidate
Keywords: Bariatric surgery
Bariatrics
Local anesthetic
Ropivacaine
Intraperitoneal
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 0-1 h Postoperative Pain Level
timeFrame: 0-1 hours post operatively
measure: 1-2 h Postoperative Pain Level
timeFrame: 1-2 hours post operatively
measure: 2-4 Hours Post Operative Pain Level
timeFrame: 2-4 hours post operatively
measure: 4-8 Hours Post Operative Pain Level
timeFrame: 4-8 hours post operatively
measure: 8-12 Hours Post Operative Pain Level
timeFrame: 8-12 hours post operatively
measure: 12-16 Hours Post Operative Pain Level
timeFrame: 12-16 hours post operatively
measure: 16-20 Hours Post Operative Pain Level
timeFrame: 16-20 hours post operatively
measure: 20-24 Hours Post Operative Pain Level
timeFrame: 20-24 hours post operatively
measure: 24-32 Hours Post Operative Pain Level
timeFrame: 24-32 hours post operatively
measure: 32-40 Hours Post Operative Pain Level
timeFrame: 32-40 hours post operatively
measure: 40-48 Hours Post Operative Pain Level
timeFrame: 40-48 hours post operatively
Secondary outcomes:
measure: 1h Peak Expiratory Flow (PEF) Score
timeFrame: 1 hours post operatively
measure: 2h Peak Expiratory Flow (PEF) Score
timeFrame: 2 hours post operatively
measure: 4h Peak Expiratory Flow (PEF) Score
timeFrame: 4 hours post operatively
measure: 8h Peak Expiratory Flow (PEF) Score
timeFrame: 8 hours post operatively
measure: 12h Peak Expiratory Flow (PEF) Score
timeFrame: 12 hours post operatively
measure: 16h Peak Expiratory Flow (PEF) Score
timeFrame: 16 hours post operatively
measure: 20h Peak Expiratory Flow (PEF) Score
timeFrame: 20 hours post operatively
measure: 24h Peak Expiratory Flow (PEF) Score
timeFrame: 24 hours post operatively
measure: 32h Peak Expiratory Flow (PEF) Score
timeFrame: 32 hours post operatively
measure: 40h Peak Expiratory Flow (PEF) Score
timeFrame: 40 hours post operatively
measure: 48h Peak Expiratory Flow (PEF) Score
timeFrame: 48 hours post operatively
measure: 6 Minute Walking Distance Post Operative Day 1 (POD1)
timeFrame: Post operative day 1
measure: 6 Minute Walking Distance Post Operative Day 2 (POD2)
timeFrame: Post operative day 2
measure: Postoperative Day 1 Quality of Recovery Questionnaire (QR-40)
timeFrame: Post operative day 1
measure: 0-1 h Postoperative Tylenol Consumption
timeFrame: 0-1 hours post operatively
measure: 0-1 h Postoperative Ketorolac Consumption
timeFrame: 0-1 hours post operatively
measure: 0-1 h Postoperative Dilaudid Consumption
timeFrame: 0-1 hours post operatively
measure: 0-1 h Postoperative Tramadol Consumption
timeFrame: 0-1 h Postoperative Tramadol consumption
measure: 0-1 h Postoperative Fentanyl Consumption
timeFrame: 0-1 hours post operatively
measure: 1-2 h Postoperative Tylenol Consumption
timeFrame: 1-2 hours post operatively
measure: 1-2 h Postoperative Ketorolac Consumption
timeFrame: 1-2 hours post operatively
measure: 1-2 h Postoperative Dilaudid Consumption
timeFrame: 1-2 hours post operatively
measure: 1-2 h Postoperative Tramadol Consumption
timeFrame: 1-2 hours post operatively
measure: 1-2 h Postoperative Fentanyl Consumption
timeFrame: 1-2 hours post operatively
measure: 2-4 h Postoperative Tylenol Consumption
timeFrame: 2-4 hours post operatively
measure: 2-4 h Postoperative Ketorolac Consumption
timeFrame: 2-4 hours post operatively
measure: 2-4 h Postoperative Dilaudid Consumption
timeFrame: 2-4 hours post operatively
measure: 2-4 h Postoperative Tramadol Consumption
timeFrame: 2-4 hours post operatively
measure: 2-4 h Postoperative Fentanyl Consumption
timeFrame: 2-4 hours post operatively
measure: 4-12 h Postoperative Tylenol Consumption
timeFrame: 4-12 hours post operatively
measure: 4-12 h Postoperative Ketorolac Consumption
timeFrame: 4-12 hours post operatively
measure: 4-12 h Postoperative Tramadol Consumption
timeFrame: 4-12 hours post operatively
measure: 4-12 h Postoperative Dilaudid Consumption
timeFrame: 4-12 hours post operatively
measure: 12-24 h Postoperative Tylenol Consumption
timeFrame: 12-24 hours post operatively
measure: 12-24 h Postoperative Ketorolac Consumption
timeFrame: 12-24 hours post operatively
measure: 12-24 h Postoperative Tramadol Consumption
timeFrame: 12-24 hours post operatively
measure: 12-24 h Postoperative Dilaudid Consumption
timeFrame: 12-24 hours post operatively
measure: 24-48 h Postoperative Tylenol Consumption
timeFrame: 24-48 hours post operatively
measure: 24-48 h Postoperative Ketorolac Consumption
timeFrame: 24-48 hours post operatively
measure: 24-48 h Postoperative Tramadol Consumption
timeFrame: 24-48 hours post operatively
measure: 24-48 h Postoperative Dilaudid Consumption
timeFrame: 24-48 hours post operatively
measure: Postoperative Day 7-10 Quality of Recovery Questionnaire (QR-40)
timeFrame: Post operative day 7-10
measure: 6 Minute Walking Distance Post Operative Day 7-10 (POD 7-10)
timeFrame: Post operative day 7-10 (Follow-up Clinic)
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Joseph Mamazza, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jarrar A, Eipe N, Wu R, Neville A, Yelle JD, Mamazza J. Effect of intraperitoneal local anesthesia on enhanced recovery outcomes after bariatric surgery: a randomized controlled pilot study. Can J Surg. 2021 Nov 10;64(6):E603-E608. doi: 10.1503/cjs.017719. Print 2021 Nov-Dec.
citation: Wu R, Haggar F, Porte N, Eipe N, Raiche I, Neville A, Yelle JD, Ramsay T, Mamazza J. Assessing the feasibility of a randomised, double-blinded, placebo-controlled trial to investigate the role of intraperitoneal ropivacaine in gastric bypass surgery: a protocol. BMJ Open. 2014 Aug 11;4(8):e005823. doi: 10.1136/bmjopen-2014-005823.