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| Sponsored by: |
Meir Medical Center |
|---|---|
| Information provided by: | Meir Medical Center |
| ClinicalTrials.gov Identifier: | NCT00799149 |
Purpose
To determine that when administered as part of a multimodal analgesic regimen, use of the new COX-2 antagonist etoricoxib (120 mg/day, per os) is more effective in improving postoperative pain management after knee arthroscopy than gabapentin (1.2 g/day, per os).
| Condition | Intervention | Phase |
|---|---|---|
|
Knee Arthroscopy |
Drug: Gabapentin, Etoricoxib, Sugar pill |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Phase 4 Study Comparing the Efficacy of Etoricoxib Versus Gabapentin as Part of a Multimodal Analgesic Regimen for Ambulatory Knee Arthroscopy |
| Enrollment: | 75 |
| Study Start Date: | June 2006 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Gabapentin: Active Comparator
Gabapentin (1200 mg) administered 30-90 min before the patient entered the operating room; Subsequent doses of Gabapentin (1200 mg)were administered on the mornings (08H00) of the first, second, and third postoperative days.
|
Drug: Gabapentin, Etoricoxib, Sugar pill
Control (Sugar pill) or gabapentin (1200 mg) or etoricoxib (120 mg) administered 30-90 min before the patient entered the operating room with a sip of water. Subsequent doses of the oral study drugs were administered on the mornings (08H00) of the first, second, and third postoperative days. .
|
|
Etoricoxib: Active Comparator
Etoricoxib (120 mg)administered 30-90 min before the patient entered the operating room; Subsequent doses of etoricoxib (120 mg)were administered on the mornings (08H00) of the first, second, and third postoperative days.
|
Drug: Gabapentin, Etoricoxib, Sugar pill
Control (Sugar pill) or gabapentin (1200 mg) or etoricoxib (120 mg) administered 30-90 min before the patient entered the operating room with a sip of water. Subsequent doses of the oral study drugs were administered on the mornings (08H00) of the first, second, and third postoperative days. .
|
|
Sugar pill: Placebo Comparator
Sugar pill administered 30-90 min before the patient entered the operating room. Subsequent doses of Sugar pill were administered on the mornings (08H00) of the first, second, and third postoperative days.
|
Drug: Gabapentin, Etoricoxib, Sugar pill
Control (Sugar pill) or gabapentin (1200 mg) or etoricoxib (120 mg) administered 30-90 min before the patient entered the operating room with a sip of water. Subsequent doses of the oral study drugs were administered on the mornings (08H00) of the first, second, and third postoperative days. .
|
Background: Post-discharge pain remains a significant problem after many ambulatory surgery procedures. Both etoricoxib and gabapentin have been used to prevent postoperative pain; however their relative efficacy in the post-discharge period is not known. We hypothesized that daily use of etoricoxib would offer advantages over gabapentin as part of a multimodal analgesic regimen in the perioperative period due to its pharmacokinetic profile.
Methods: Seventy-five healthy outpatients undergoing elective ambulatory knee arthroscopy were randomly assigned to receive identical-appearing capsules containing either a placebo, gabapentin (1.2g, or etoricoxib 120 mg, 30-90 min before skin incision and at 08H00 on the first, second, and third postoperative days. Post-discharge pain was treated with "rescue" dipyrone syrup (500 mg). Pain intensity (as assessed using a 100 visual analog scale), dipyrone usage, and the incidence of nausea and vomiting, sedation and anxiety were recorded at specific time intervals in the postoperative period. The recovery of functional activity was assessed at 96 h after surgery using a validated questionnaire.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Department of Anesthesiology, Meir Medical Center, Kfar Sava ( Masha Zakotski MD ) |
| Study ID Numbers: | MMC-045-06 |
| Study First Received: | November 26, 2008 |
| Last Updated: | November 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00799149 History of Changes |
| Health Authority: | Israel: Ethics Commission |
|
Post-operative pain Knee arthroscopy Gabapentin Etoricoxib Elective ambulatory knee arthroscopy |
|
Anti-Inflammatory Agents Excitatory Amino Acids Neurotransmitter Agents Tranquilizing Agents Gabapentin Cyclooxygenase Inhibitors Etoricoxib Psychotropic Drugs Calcium Channel Blockers Central Nervous System Depressants Pain |
Cardiovascular Agents Antimanic Agents Calcium, Dietary Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal Anti-Anxiety Agents Analgesics Peripheral Nervous System Agents Antirheumatic Agents Pain, Postoperative Anticonvulsants |
|
Anti-Inflammatory Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Gabapentin Physiological Effects of Drugs Psychotropic Drugs Calcium Channel Blockers Antiparkinson Agents Excitatory Amino Acid Agents Membrane Transport Modulators Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Excitatory Amino Acid Antagonists Tranquilizing Agents Etoricoxib Cyclooxygenase Inhibitors Central Nervous System Depressants Enzyme Inhibitors Cardiovascular Agents Antimanic Agents Pharmacologic Actions Analgesics, Non-Narcotic Anti-Anxiety Agents Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Anticonvulsants |
