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Preoperative Pain Control in Gastric Bypass Surgery Patients

Primary Purpose

Post-operative Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pregabalin
Placebo (for Pregabalin)
Sponsored by
Legacy Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • Legacy Good Samaritan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pregabalin

Sugar Pill

Arm Description

Single, 300 mg pre-operative oral dose of Pregabalin.

Single, placebo pre-operative dose.

Outcomes

Primary Outcome Measures

Post-operative Pain Medication Requirements

Secondary Outcome Measures

Length of Stay
Length of stay in days after surgical procedure

Full Information

First Posted
February 5, 2013
Last Updated
July 12, 2022
Sponsor
Legacy Health System
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1. Study Identification

Unique Protocol Identification Number
NCT01801189
Brief Title
Preoperative Pain Control in Gastric Bypass Surgery Patients
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Legacy Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin
Arm Type
Experimental
Arm Description
Single, 300 mg pre-operative oral dose of Pregabalin.
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
Single, placebo pre-operative dose.
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
Lyrica
Intervention Description
One 300 mg oral dose of Pregabalin given before surgery.
Intervention Type
Drug
Intervention Name(s)
Placebo (for Pregabalin)
Other Intervention Name(s)
Sugar pill manufactured to mimic Pregabalin 300 mg tablet
Intervention Description
One oral dose of placebo given before surgery.
Primary Outcome Measure Information:
Title
Post-operative Pain Medication Requirements
Time Frame
Morphine milligram equivalent opioid requirements on post op days zero, 1, and 2.
Secondary Outcome Measure Information:
Title
Length of Stay
Description
Length of stay in days after surgical procedure
Time Frame
Days in hospital following surgical procedure, up to 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing laparoscopic Roux-en-Y gastric bypass surgery. Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie Halpin, MD
Organizational Affiliation
Legacy Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Legacy Good Samaritan Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Preoperative Pain Control in Gastric Bypass Surgery Patients

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