Postoperative Pain | Clinical Trial of Gabapentin to Improve Postoperative Pain in Surgical Patients
Postoperative Pain research study
What is the primary objective of this study?
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 amount of postoperative pain, narcotic requirements, and postoperative delirium and cognitive dysfunction between the two groups.
Who is eligible to participate?
Inclusion Criteria: - Male or female ≥45 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).
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:GabapentinThis is a Double blind, placebo-controlled experimental study in which gabapentin adjusted for renal clearance (or placebo) is given preoperatively and also the first three postoperative days
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
GabapentinDouble blind, placebo controlled
Start Date: January 2006
Completed Date: July 2014
Phase: Phase 3
Primary Outcome: Postoperative delirium and cognitive decline
Secondary Outcome: Postoperative opioid doses and pain scores
Study sponsors, principal investigator, and references
Principal Investigator: Jacqueline M Leung, MD, MPH
Lead Sponsor: University of California, San Francisco
Leung JM, Sands LP, Rico M, Petersen KL, Rowbotham MC, Dahl JB, Ames C, Chou D, Weinstein P. Pilot clinical trial of gabapentin to decrease postoperative delirium in older patients. Neurology. 2006 Oct 10;67(7):1251-3. Epub 2006 Aug 16.