Effect of Gabapentin on Orthopedic Pain
This study is being done to determine if a drug called gabapentin helps in the postoperative management of patients undergoing hip and knee operations. The investigators wish to determine the effect of gabapentin on pain and sleep following surgery. If we can lessen a patient's pain and improve sleep, the patient will be better able to participate in their physical therapy. Gabapentin has already been shown to lessen postoperative pain when given before surgery. In healthy patients, it has also been shown to improve certain aspects of sleep. We hope to identify the effect of the drug, when given after surgery, on patients' pain and sleep.
Degenerative Joint Disease of Hip and Knee.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effect of Gabapentin on Postoperative Pain: a Randomized, Double Blind, Placebo Controlled Trial|
- The primary endpoint will be opioid consumption [ Time Frame: 48 hours ] [ Designated as safety issue: No ]Total opioid consumption and lowest/highest pain score in 8 hour segments.
- sleep scales [ Time Frame: 48 hours post operatively ] [ Designated as safety issue: No ]Pittsburgh Sleep Quality Index.
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: placebo
Placebo one dose in the evening of surgery and post op day #1.
Active Comparator: Gabapentin
Gabapentin 400mg orally at 9pm on the evening of surgery and first day post operatively
400mg orally at 9pm day of surgery and the first evening post operatively.
Other Name: Neurontin
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01546857
|Contact: Daniel J. Eloy, MD||973 firstname.lastname@example.org|
|Contact: Catherine Schoenberg, BSN||973 email@example.com|
|United States, New Jersey|
|Newark, New Jersey, United States, 07101|
|Contact: Daniel Eloy, MD 973-972-5254 firstname.lastname@example.org|
|Contact: Catherine Schoenberg, BSN 973 972-7477 email@example.com|
|Principal Investigator: Daniel Eloy, MD|
|Sub-Investigator: Steven Shulman, MD|