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)
1 other identifier
interventional
61
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 postoperative-pain
Started Feb 2013
Longer than P75 for phase_4 postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 5, 2013
CompletedFirst Posted
Study publicly available on registry
February 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
June 6, 2022
CompletedJuly 14, 2022
July 1, 2022
2.8 years
February 5, 2013
April 6, 2022
July 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Post-operative Pain Medication Requirements
Morphine milligram equivalent opioid requirements on post op days zero, 1, and 2.
Secondary Outcomes (1)
Length of Stay
Days in hospital following surgical procedure, up to 5 days
Study Arms (2)
Pregabalin
EXPERIMENTALSingle, 300 mg pre-operative oral dose of Pregabalin.
Sugar Pill
PLACEBO COMPARATORSingle, placebo pre-operative dose.
Interventions
One 300 mg oral dose of Pregabalin given before surgery.
One oral dose of placebo given before surgery.
Eligibility Criteria
You may qualify if:
- Patients undergoing laparoscopic Roux-en-Y gastric bypass surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Legacy Good Samaritan Medical Center
Portland, Oregon, 97210, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Valerie Halpin
- Organization
- Legacy Weight and Diabetes Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Valerie Halpin, MD
Legacy Health System
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 5, 2013
First Posted
February 28, 2013
Study Start
February 1, 2013
Primary Completion
December 1, 2015
Study Completion
January 1, 2016
Last Updated
July 14, 2022
Results First Posted
June 6, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share