Etoricoxib Versus Gabapentin for Knee Arthroscopy

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Phase 4 Study Comparing the Efficacy of Etoricoxib Versus Gabapentin as Part of a Multimodal Analgesic Regimen for Ambulatory Knee Arthroscopy

Conditions
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Knee Arthroscopy

Intervention / Treatment
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* Drug: Gabapentin, Etoricoxib, Sugar pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective ambulatory knee arthroscopy Exclusion Criteria: History of clinically-significant cardiovascular,pulmonary,hepatic,renal, neurologic, psychiatric or metabolic disease Patients chronically receiving pain killers

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gabapentin<br>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<br>* 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. .<br>|
| Active Comparator: Etoricoxib<br>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<br>* 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. .<br>|
| Placebo Comparator: Sugar pill<br>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<br>* 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. .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1)Pain intensity (as assessed using a 100 visual analog scale) 2)Incidence of dipyrone usage |  | 96 hours post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The recovery of functional activity |  | 96 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-operative pain, Knee arthroscopy, Gabapentin, Etoricoxib, Elective ambulatory knee arthroscopy