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Completed

NCT Number: NCT01801189

Preoperative Pain Control in Gastric Bypass Surgery Patients

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.

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Key information

Conditions

Post-operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Legacy Good Samaritan Medical Center

Portland, Oregon, 97210, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Pregabalin

Drug

One 300 mg oral dose of Pregabalin given before surgery.

Other names: Lyrica

Placebo (for Pregabalin)

Drug

One oral dose of placebo given before surgery.

Other names: Sugar pill manufactured to mimic Pregabalin 300 mg tablet

Primary outcomes

  1. Post-operative Pain Medication Requirements

    Time frame: Morphine milligram equivalent opioid requirements on post op days zero, 1, and 2.

Secondary outcomes

  1. Length of Stay

    Time frame: Days in hospital following surgical procedure, up to 5 days

    Length of stay in days after surgical procedure

Sponsors and collaborators

Lead sponsor

Legacy Health System

Other

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Feb 28, 2013
Registry last updated
Jul 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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