Knee Arthroscopy Clinical Trial
Official title:
Phase 4 Study Comparing the Efficacy of Etoricoxib Versus Gabapentin as Part of a Multimodal Analgesic Regimen for Ambulatory Knee Arthroscopy
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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