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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
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.
Details
| Lead sponsor | Ottawa Hospital Research Institute |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 120 |
| Start date | 2014-07 |
| Completion | 2015-07 |
Conditions
- Bariatric Surgery Candidate
Interventions
- Ropivacaine
- Normal Saline
Primary outcomes
- 0-1 h Postoperative Pain Level — 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). - 1-2 h Postoperative Pain Level — 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). - 2-4 Hours Post Operative Pain Level — 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). - 4-8 Hours Post Operative Pain Level — 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). - 8-12 Hours Post Operative Pain Level — 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). - 12-16 Hours Post Operative Pain Level — 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).
Countries
Canada