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)

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.

Study Overview

• Status: Completed
• Conditions: Post-operative Pain
• Intervention / Treatment: Drug: Pregabalin; Drug: Placebo (for Pregabalin)

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 Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97210
      • Legacy Good Samaritan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pregabalin; Single, 300 mg pre-operative oral dose of Pregabalin.	Drug: Pregabalin; One 300 mg oral dose of Pregabalin given before surgery.; Other Names: Lyrica
Placebo Comparator: Sugar Pill; Single, placebo pre-operative dose.	Drug: Placebo (for Pregabalin); One oral dose of placebo given before surgery.; Other Names: Sugar pill manufactured to mimic Pregabalin 300 mg tablet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay	Length of stay in days after surgical procedure	Days in hospital following surgical procedure, up to 5 days

Collaborators and Investigators

• Sponsor: Legacy Health System
• Investigators: Principal Investigator: Valerie Halpin, MD, Legacy Health System

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: February 5, 2013
• First Submitted That Met QC Criteria: February 26, 2013
• First Posted (Estimate): February 28, 2013

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anti-Anxiety Agents; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Pregabalin
• Other Study ID Numbers: H001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No