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Sponsored by: |
University of California, San Francisco |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00221338 |
This will be a double blind, placebo-controlled study of patients ≥45 years of age undergoing surgery of the spine 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 |
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Postoperative Pain |
Drug: Gabapentin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Clinical Trial of Gabapentin to Improve Postoperative Pain in Surgical Patients |
Estimated Enrollment: | 312 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | July 2013 |
Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Gabapentin: Placebo Comparator
already described
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Drug: Gabapentin
gabapentin adjusted for renal clearance given preoperatively and also the first three postoperative days
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Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jacqueline M Leung, MD, MPH | 415-476-0711 | leungj@anesthesia.ucsf.edu |
Contact: Laura Sands, PhD | 765-494-4037 | lsands@nursing.purdue.edu |
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 |
Principal Investigator: | Jacqueline M Leung, MD, MPH | University of California, San Francisco, CA, USA |
Responsible Party: | University of California, San Francisco ( Jacqueline M. Leung, MD, MPH ) |
Study ID Numbers: | H5636-26795-01 |
Study First Received: | September 19, 2005 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00221338 History of Changes |
Health Authority: | United States: Institutional Review Board |
gabapentin pain surgery delirium cognitive decline |
Excitatory Amino Acids Neurotransmitter Agents Tranquilizing Agents Gabapentin Psychotropic Drugs Central Nervous System Depressants Calcium Channel Blockers Pain Cardiovascular Agents Antimanic Agents |
Signs and Symptoms Calcium, Dietary Postoperative Complications Anti-Anxiety Agents Analgesics Peripheral Nervous System Agents Pain, Postoperative Anticonvulsants Delirium |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Gabapentin Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Pain Membrane Transport Modulators Signs and Symptoms Pathologic Processes Sensory System Agents |
Therapeutic Uses Analgesics Pain, Postoperative Excitatory Amino Acid Antagonists Tranquilizing Agents Central Nervous System Depressants Cardiovascular Agents Antimanic Agents Pharmacologic Actions Postoperative Complications Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |