Preoperative Pain Control in Gastric Bypass Surgery Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01801189|
Recruitment Status : Completed
First Posted : February 28, 2013
Last Update Posted : March 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Post-operative Pain||Drug: Pregabalin Drug: Placebo (for Pregabalin)||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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 Start Date :||February 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||January 2016|
Single, 300 mg pre-operative oral dose of Pregabalin.
One 300 mg oral dose of Pregabalin given before surgery.
Other Name: Lyrica
Placebo Comparator: Sugar Pill
Single, placebo pre-operative dose.
Drug: Placebo (for Pregabalin)
One oral dose of placebo given before surgery.
Other Name: Sugar pill manufactured to mimic Pregabalin 300 mg tablet
- Post-operative pain medication requirements [ Time Frame: Evaluated every 4 hours and 1 hour after pain medications are given post-operatively during hospitalization, for up to 5 days. ]
- Post-operative Pain Scale [ Time Frame: Evaluated every 4 hours and 1 hour after pain medications are given post-operatively during hospitalization, for up to 5 days. ]
- Episodes of vomiting [ Time Frame: Evaluated every 4 hours and 1 hour after pain medications are given post-operatively during hospitalization, for up to 5 days. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801189
|United States, Oregon|
|Legacy Good Samaritan Medical Center|
|Portland, Oregon, United States, 97210|
|Principal Investigator:||Valerie Halpin, MD||Legacy Health System|