Phase 3
Completed N=120
The Use of Intraperitoneal Ropivacaine in Bariatric Bypass Surgery
Bariatric Surgery Candidate
Source: ClinicalTrials.gov NCT02154763 ↗
Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: 0-1 h Postoperative Pain Level — 3.9762; 4.3149 units on a scale
◆ Published Evidence
Emerging
12citations · ~2 / year
Effect of intraperitoneal local anesthesia on enhanced recovery outcomes after bariatric surgery: a randomized controlled pilot study.
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.
Linked Publications (2)
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Effect of intraperitoneal local anesthesia on enhanced recovery outcomes after bariatric surgery: a randomized controlled pilot study.
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Assessing the feasibility of a randomised, double-blinded, placebo-controlled trial to investigate the role of intraperitoneal ropivacaine in gastric bypass surgery: a protocol.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT02154763) and the linked publication. 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. Informational only — not medical advice.