Effect of Gabapentin on Orthopedic Pain
Stopped early · Phase 4 · Has a placebo group
Conditions studied: Degenerative Arthritis and Postoperative Pain
In brief
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.
Key facts
- Study ID
- NCT01546857
- Run by
- Rutgers, The State University of New Jersey
- People needed
- 34
- Starts
- 2012-03-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2021-01-19
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Undergoing a hip arthroplasty, total knee arthroplasty, hip fracture repair American Society of Anesthesiologist rating I-III as determined by your anesthesiologist
You may not qualify if…
- Pregnancy and breast feeding
- An allergy to any of the drugs to be used in the study (midazolam, Celecoxib, gabapentin, hydromorphone, bupivacaine)
- History of a sleep disorder (Obstructive sleep apnea or daytime somnolence)
- History of taking chronic narcotic pain medications or gabapentin
- History of rheumatoid arthritis, a psychiatric disorder, or diabetes with impaired renal function
- History of alcohol or illicit drug abuse.
- History of a kidney or liver problem.
- Inability or unwilling to use patient-controlled analgesia.
- Unable to meet the criteria for removal of the endotracheal tube in the Operating Room
- History of asthma, hives or an allergic type reaction following an aspirin or other NSAIDS drug such as Ibuprofen.
- History of stroke or heart attack or thrombotic event within the past 3 months
- Lactose intolerance
- History of cardiac surgery
Where it is running
- University Hospital — Newark, New Jersey, United States
Full record on ClinicalTrials.gov
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