Clinical Trial of Gabapentin to Improve Postoperative Pain in Surgical Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00221338
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : July 15, 2015
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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 amount of postoperative pain, narcotic requirements, and postoperative delirium and cognitive dysfunction between the two groups.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Gabapentin Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial of Gabapentin to Improve Postoperative Pain in Surgical Patients
Study Start Date : January 2006
Actual Primary Completion Date : January 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Gabapentin
Double blind, placebo controlled
Drug: Gabapentin
This 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
Other Name: gabapentin versus placebo

Primary Outcome Measures :
  1. Postoperative delirium and cognitive decline [ Time Frame: postoperative days 1, 2 and 3 ]

Secondary Outcome Measures :
  1. Postoperative opioid doses and pain scores [ Time Frame: postoperative days 1, 2 and 3 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00221338

United States, California
University of California, San Francisco
San Francisco, California, United States, 94143-0648
Sponsors and Collaborators
University of California, San Francisco
Principal Investigator: Jacqueline M Leung, MD, MPH University of California, San Francisco, CA, USA

Publications of Results:
Responsible Party: University of California, San Francisco Identifier: NCT00221338     History of Changes
Other Study ID Numbers: H5636-26795-01
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: July 15, 2015
Last Verified: July 2015

Keywords provided by University of California, San Francisco:
cognitive decline

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
gamma-Aminobutyric Acid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents