Status:
UNKNOWN
The Use of Laparoscopic Transversus Abdominis Plane Block in Gastric Bypass Surgery (LapTAP)
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Bariatric Surgery Candidate
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Randomized, Double-Blinded, Placebo-Controlled Trial of Laparoscopic Transverse Abdominis Plane (Lap TAP) and Rectus Sheath Block in elective Gastric Bypass Surgery aiming to evaluate the benefit of a...
Detailed Description
Management of post-operative pain remains a major challenge and an area of continued research. Effective pain control, apart from providing general patient comfort, is critical for a variety of clinic...
Eligibility Criteria
Inclusion
- 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
- Patient undergoing planned sleeve gastrectomy (intra-op conversion to sleeve gastrectomy after delivery of Ropivacaine/placebo 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/min)
- Patients with hepatic dysfunction Child-Pugh Class B or C
- Patients with previous foregut surgery including esophageal, gastric, liver, and pancreas resections
- Patients weighing less than or equal to 100 kilograms as measured in the pre-admission unit
- Patients enrolled in any other study involving involve tissue biopsy.
- Patients with Chronic Pain and Chronic Opioid use- Oral Morphine Equivalent of \>100mg/day
Key Trial Info
Start Date :
November 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2020
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03367728
Start Date
November 27 2018
End Date
February 1 2020
Last Update
November 6 2019
Active Locations (1)
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1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9