Phase 3 N=120 Randomized Quadruple-blind Treatment

The Use of Intraperitoneal Ropivacaine in Bariatric Bypass Surgery

Bariatric Surgery Candidate

Bottom Line

View on ClinicalTrials.gov: NCT02154763 ↗

Enrolled (actual)

120

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcome: Primary: 0-1 h Postoperative Pain Level — 3.9762; 4.3149 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ropivacaine (Drug); Normal Saline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ottawa Hospital Research Institute
Primary completion: Jan 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY 0-1 h Postoperative Pain Level	3.9762; 4.3149	—
PRIMARY 1-2 h Postoperative Pain Level	3.5307; 3.6911	—
PRIMARY 2-4 Hours Post Operative Pain Level	3.2733; 3.1978	—
PRIMARY 4-8 Hours Post Operative Pain Level	3.6507; 3.8387	—
PRIMARY 8-12 Hours Post Operative Pain Level	3.7955; 3.9056	—
PRIMARY 12-16 Hours Post Operative Pain Level	3.4419; 3.9444	—
PRIMARY 16-20 Hours Post Operative Pain Level	3.4186; 3.8081	—
PRIMARY 20-24 Hours Post Operative Pain Level	3.2386; 3.4651	—
PRIMARY 24-32 Hours Post Operative Pain Level	3.2568; 3.1974	—
PRIMARY 32-40 Hours Post Operative Pain Level	2.8143; 2.9955	—
PRIMARY 40-48 Hours Post Operative Pain Level	2.7661; 2.9394	—
SECONDARY 1h Peak Expiratory Flow (PEF) Score	202.9; 200.3	—
SECONDARY 2h Peak Expiratory Flow (PEF) Score	243; 239.8	—
SECONDARY 4h Peak Expiratory Flow (PEF) Score	251.9; 256.1	—
SECONDARY 8h Peak Expiratory Flow (PEF) Score	250.9; 255.3	—
SECONDARY 12h Peak Expiratory Flow (PEF) Score	240; 241.6	—
SECONDARY 16h Peak Expiratory Flow (PEF) Score	233.4; 242.2	—
SECONDARY 20h Peak Expiratory Flow (PEF) Score	246; 245.1	—
SECONDARY 24h Peak Expiratory Flow (PEF) Score	255.2; 253.8	—
SECONDARY 32h Peak Expiratory Flow (PEF) Score	256.62; 265.5	—
SECONDARY 40h Peak Expiratory Flow (PEF) Score	255.3; 265.8	—
SECONDARY 48h Peak Expiratory Flow (PEF) Score	285.3; 285.3	—
SECONDARY 6 Minute Walking Distance Post Operative Day 1 (POD1)	205.8; 182.4	—
SECONDARY 6 Minute Walking Distance Post Operative Day 2 (POD2)	260; 217.2	—
SECONDARY Postoperative Day 1 Quality of Recovery Questionnaire (QR-40)	163; 163.6	—
SECONDARY 0-1 h Postoperative Tylenol Consumption	72.2222; 49.2391	—
SECONDARY 0-1 h Postoperative Ketorolac Consumption	5; 6.413	—
SECONDARY 0-1 h Postoperative Dilaudid Consumption	1008.9; 925	—
SECONDARY 0-1 h Postoperative Tramadol Consumption	3.3333; 2.1739	—
SECONDARY 0-1 h Postoperative Fentanyl Consumption	45.5556; 42.9348	—
SECONDARY 1-2 h Postoperative Tylenol Consumption	144.2; 141.3	—
SECONDARY 1-2 h Postoperative Ketorolac Consumption	2.3333; 2.3913	—
SECONDARY 1-2 h Postoperative Dilaudid Consumption	291.1; 489.1	—
SECONDARY 1-2 h Postoperative Tramadol Consumption	9.4444; 8.6957	—
SECONDARY 1-2 h Postoperative Fentanyl Consumption	10; 7.6087	—
SECONDARY 2-4 h Postoperative Tylenol Consumption	216.4; 240.2	—
SECONDARY 2-4 h Postoperative Ketorolac Consumption	3.2222; 1.0087	—
SECONDARY 2-4 h Postoperative Dilaudid Consumption	415.6; 484.8	—
SECONDARY 2-4 h Postoperative Tramadol Consumption	12.2222; 15.2174	—
SECONDARY 2-4 h Postoperative Fentanyl Consumption	4.4444; 33.1522	—
SECONDARY 4-12 h Postoperative Tylenol Consumption	1140.9; 1187	—
SECONDARY 4-12 h Postoperative Ketorolac Consumption	6.8889; 5.2174	—
SECONDARY 4-12 h Postoperative Tramadol Consumption	81.1111; 85.8696	—
SECONDARY 4-12 h Postoperative Dilaudid Consumption	2000; 1830.4	—
SECONDARY 12-24 h Postoperative Tylenol Consumption	1921.1; 1837	—
SECONDARY 12-24 h Postoperative Ketorolac Consumption	6.3333; 5.5435	—
SECONDARY 12-24 h Postoperative Tramadol Consumption	141.1; 138	—
SECONDARY 12-24 h Postoperative Dilaudid Consumption	2066.7; 2760.9	—
SECONDARY 24-48 h Postoperative Tylenol Consumption	3033.3; 2826.1	—
SECONDARY 24-48 h Postoperative Ketorolac Consumption	2.3333; 3.2609	—
SECONDARY 24-48 h Postoperative Tramadol Consumption	216.7; 215.2	—
SECONDARY 24-48 h Postoperative Dilaudid Consumption	2933.3; 3000	—
SECONDARY Postoperative Day 7-10 Quality of Recovery Questionnaire (QR-40)	183.5; 182.7	—
SECONDARY 6 Minute Walking Distance Post Operative Day 7-10 (POD 7-10)	373.3; 352.4	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02154763). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.