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Sponsored by: |
Mayo Clinic |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00588159 |
One dose of either gabapentin or placebo will be given to patients prior to thoracotomy. Patients will also receive an epidural infusion, intravenous patient-controlled analgesia with fentanyl, oral acetaminophen and intravenous ketorolac as needed to achieve optimal analgesia. Pain ratings and supplemental medication use will be recorded for 48 hours and will also be assessed at 3 months postoperatively to determine whether the patients who received gabapentin had improved analgesia and/or required less supplemental medication than the placebo group.
Condition | Intervention |
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Thoracotomy |
Drug: Gabapentin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Preoperative Gabapentin for Acute and Chronic Post-Thoracotomy Analgesia: A Randomized, Double-Blinded, Placebo-Controlled Study |
Estimated Enrollment: | 120 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | August 2009 |
Arms | Assigned Interventions |
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1: Experimental
Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
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Drug: Gabapentin
600 mg gabapentin p.o. preoperatively within 2 hours prior to surgery
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2: Placebo Comparator
Diphenhydramine 12.5 mg p.o. is the active placebo given 2 hours prior to surgery.
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Drug: Gabapentin
600 mg gabapentin p.o. preoperatively within 2 hours prior to surgery
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The gabapentin dose utilized is 600 mg. The epidural infusion utilizes bupivacaine 0.075% with hydromorphone 10 mcg/cc infusing at 6 cc/hour. The settings for the fentanyl patient-controlled analgesia device start at 10 mcg every 10 minutes with a 200 mcg 4 hour maximum.
Ages Eligible for Study: | 50 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Michelle A Kinney, M.D. 507-266-9877 kinney.michelle@mayo.edu | |
Principal Investigator: Michelle A Kinney, M.D. |
Principal Investigator: | Michelle A. Kinney, M.D. | Mayo Clinic |
Responsible Party: | Mayo Clinic ( Michelle Kinney, M.D. ) |
Study ID Numbers: | 05-004145 |
Study First Received: | December 18, 2007 |
Last Updated: | January 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00588159 History of Changes |
Health Authority: | United States: Institutional Review Board |
Preoperative gabapentin Acute pain Post-thoracotomy pain Epidural analgesia |
Excitatory Amino Acids Neurotransmitter Agents Tranquilizing Agents Gabapentin Psychotropic Drugs Calcium Channel Blockers Central Nervous System Depressants Pain |
Cardiovascular Agents Antimanic Agents Calcium, Dietary Anti-Anxiety Agents Analgesics Peripheral Nervous System Agents Anticonvulsants |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Gabapentin Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Cardiovascular Agents |
Antimanic Agents Pharmacologic Actions Membrane Transport Modulators Sensory System Agents Therapeutic Uses Anti-Anxiety Agents Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants Excitatory Amino Acid Antagonists |