NCT01801189

Preoperative Pain Control in Gastric Bypass Surgery Patients

A Randomized Placebo-Controlled Study of Whether Pre-operative Pregabalin 300 mg Will Improve Pain Control in Patients Undergoing Laparoscopic Roux-en-Y Gastric Bypass (Bariatric Surgery)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Legacy Health System · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Post-operative Pain

Interventions

Type	Name	Description
DRUG	Pregabalin	One 300 mg oral dose of Pregabalin given before surgery.
DRUG	Placebo (for Pregabalin)	One oral dose of placebo given before surgery.

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2013-02-28
• Last updated: 2022-07-14
• Results posted: 2022-06-06

Locations

1 site across 1 country: United States