Clinical Trial of Gabapentin to Decrease Postoperative Delirium and Pain
Completed · Phase 3 · Has a placebo group
Conditions studied: Postoperative Delirium, Postoperative Pain, Opioid Use, Hospital Length of Stay
In brief
This will be a double blind, placebo-controlled study of patients ≥65 years of age undergoing surgery of the spine, hips and knees replacement at the University of California, San Francisco (UCSF) Medical Center. Intraoperative anesthetic and postoperative pain management will be standardized. Patients will be randomized to receive either placebo or gabapentin preoperatively, and continued postoperatively until discharge. Intraoperative anesthetic and other postoperative pain management strategies will be standardized. Postoperative delirium will be measured using structured interviews. Cognitive function will be measured using a battery of neurocognitive tests pre- and post-operatively. Using an intention to treat strategy, we, the researchers at UCSF, will compare the incidence of postoperative delirium and cognitive dysfunction, the amount of postoperative pain, and narcotic requirements between the two groups. The primary outcome will be postoperative delirium. Secondary outcomes will be postoperative pain and opioids use, and length of hospital stay, and cognitive dysfunction.
Key facts
- Study ID
- NCT00221338
- Run by
- University of California, San Francisco
- People needed
- 750
- Starts
- 2006-01-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2020-09-10
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female ≥65 years of age undergoing surgery involving the spine, hip or knee replacement.
- English speaking.
- Anticipated to stay in the hospital for at least 48 hours.
You may not qualify if…
- Patients who take gabapentin preoperatively, or have known sensitivity to the drug, or those unable to be randomized to receive gabapentin.
- Subjects who are unable to provide informed consent.
- Patients with a history of narcotic tolerance.
- Patients with planned two stage spinal procedures (anterior-posterior spinal fusion to be done on two separate days).
Where it is running
- University of California, San Francisco — San Francisco, California, United States
Full record on ClinicalTrials.gov
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