Overview

Clinical Trial of Gabapentin to Decrease Postoperative Delirium and Pain

Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of California, San Francisco
Treatments:
Gabapentin
gamma-Aminobutyric Acid
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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).