Preoperative Pain Control in Gastric Bypass Surgery Patients

Phase 4

Completed

• Conditions: Post-operative Pain
• Interventions: Drug: Placebo (for Pregabalin); Drug: Pregabalin

• Registration Number: NCT01801189
• Lead Sponsor: Legacy Health System

Brief 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

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-26
• Study First Posted: 2013-02-28
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Results First Submitted: 2022-04-06
• Results First Submitted QC: 2022-06-03
• Results First Posted: 2022-06-06
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-12
• Last Update Posted: 2022-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Patients undergoing laparoscopic Roux-en-Y gastric bypass surgery.

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sugar Pill	Placebo (for Pregabalin)	Single, placebo pre-operative dose.
Pregabalin	Pregabalin	Single, 300 mg pre-operative oral dose of Pregabalin.

Primary Outcome Measures

Name	Time	Method
Post-operative Pain Medication Requirements	Morphine milligram equivalent opioid requirements on post op days zero, 1, and 2.

Secondary Outcome Measures

Name	Time	Method
Length of Stay	Days in hospital following surgical procedure, up to 5 days	Length of stay in days after surgical procedure

Trial Locations

Locations (1)

Legacy Good Samaritan Medical Center; 🇺🇸 Portland, Oregon, United States