Clinical Trial of Gabapentin to Improve Postoperative Pain in Surgical Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00221338
First received: September 19, 2005
Last updated: January 14, 2014
Last verified: January 2014
  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:


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: 750
Study Start Date: August 2005
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (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

  Show Detailed Description

  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
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, see Learn About Clinical Studies.

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: Gabriela Meckler, BS    415-476-9489    mecklerg@anesthesia.ucsf.edu   
Contact: Stacey Newman, BA    415-476-8612    newmans@anesthesia.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:
Responsible Party: 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 14, 2014
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 July 22, 2014