Clinical Trial of Gabapentin to Improve Postoperative Pain in Surgical Patients - Full Text View

Sponsor:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00221338

Purpose

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	Intervention	Phase
Postoperative Pain	Drug: Gabapentin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Clinical Trial of Gabapentin to Improve Postoperative Pain in Surgical Patients

Resource links provided by NLM:

MedlinePlus related topics: Delirium

Drug Information available for: Gabapentin Gabapentin enacarbil

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Postoperative delirium and cognitive decline [ Time Frame: postoperative days 1, 2 and 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Postoperative opioid doses and pain scores [ Time Frame: postoperative days 1, 2 and 3 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	312
Study Start Date:	August 2005
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221338

Contacts

Contact: Jacqueline M Leung, MD, MPH	415-476-0711	leungj@anesthesia.ucsf.edu
Contact: Laura Sands, PhD	765-494-4037	lsands@nursing.purdue.edu

Locations

United States, California
University of California, San Francisco	Recruiting
San Francisco, California, United States, 94143-0648
Contact: Katherine Ho 415-476-2214 Katherine.Ho@ucsf.edu
Principal Investigator: Jacqueline M Leung, MD, MPH

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator:

Jacqueline M Leung, MD, MPH

University of California, San Francisco, CA, USA

More Information

Publications:

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.

Responsible Party:	Jacqueline M. Leung, MD, MPH, University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00221338 History of Changes
Other Study ID Numbers:	H5636-26795-01
Study First Received:	September 19, 2005
Last Updated:	January 19, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

gabapentin
pain
surgery
delirium
cognitive decline

Additional relevant MeSH terms:

Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on May 21, 2012