Preoperative Pain Control in Gastric Bypass Surgery Patients

Status Completed

Clinical Trial Summary

Randomized clinical trial to evaluate whether a single pre-operative dose of Pregabalin will alleviate post-operative pain and decrease post-operative analgesic requirements in morbidly obese patients undergoing laparoscopic gastric bypass surgery.

Clinical Trial Description

Pregabalin is a popular adjunct for relieving neuropathic pain in diabetics. There have been multiple studies evaluating its use in pre and post-operative pain control in various surgeries. Post-operative pain control is a challenging problem in bariatric patients due to the high doses of narcotic required, related to the high body mass, and the danger of concomitant respiratory depression. In the obese patient, the goal of postoperative pain management is provision of comfort, early mobilization and improved respiratory function, without causing inadequate pain control, respiratory compromise or increased nausea. Methods: A Randomized Controlled Trial, whereby patients undergoing Laparoscopic Roux-en-Y gastric bypass will be administered a single pre-operative dose of Pregabalin or a placebo. We plan to follow their immediate post-operative course in the hospital, with regard to the following primary endpoints: - Post-operative analgesic requirements - Post-operative pain scale (rated 0-10) - Episodes of vomiting - Post-operative antiemetic requirement - Length of stay ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01801189
Study type	Interventional
Source	Legacy Health System
Contact
Status	Completed
Phase	Phase 4
Start date	February 2013
Completion date	January 2016

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