Clinical Trial of Gabapentin to Improve Postoperative Pain in Surgical Patients
This study is currently recruiting participants.
Verified May 2013 by University of California, San Francisco
Sponsor:
University of California, San Francisco
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00221338
First received: September 19, 2005
Last updated: May 17, 2013
Last verified: May 2013
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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
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: | May 17, 2013 |
| 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 June 18, 2013