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NCT01801189 Clinical Trial

Preoperative Pain Control in Gastric Bypass Surgery Patients

Post-operative Pain Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01801189
Other study ID # H001
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 2013
Est. completion date January 2016

Study information
Verified date July 2022
Source Legacy Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.

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

Recruitment information / eligibility
Status Completed
Enrollment 61
Est. completion date January 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Patients undergoing laparoscopic Roux-en-Y gastric bypass surgery. Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pregabalin
One 300 mg oral dose of Pregabalin given before surgery.
• Placebo (for Pregabalin)
One oral dose of placebo given before surgery.

Locations
Country Name City State
United States Legacy Good Samaritan Medical Center Portland Oregon

Sponsors (1)
Lead Sponsor Collaborator
Legacy Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Post-operative Pain Medication Requirements Morphine milligram equivalent opioid requirements on post op days zero, 1, and 2.
Secondary Length of Stay Length of stay in days after surgical procedure Days in hospital following surgical procedure, up to 5 days
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