Preoperative Pain Control in Gastric Bypass Surgery Patients

Study Overview
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Brief Summary
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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
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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

Official Title
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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)

Conditions
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Post-operative Pain

Intervention / Treatment
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* Drug: Pregabalin
* Drug: Placebo (for Pregabalin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing laparoscopic Roux-en-Y gastric bypass surgery. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |