Overview
The Use of Intraperitoneal Ropivacaine in Bariatric Bypass Surgery
Status:
Completed
Completed
Trial end date:
2015-07-01
2015-07-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Ottawa Hospital Research InstituteTreatments:
Ropivacaine
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