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Etoricoxib Versus Gabapentin for Knee Arthroscopy

Phase 4
Completed
Conditions
Knee Arthroscopy
Interventions
Drug: Gabapentin, Etoricoxib, Sugar pill
Registration Number
NCT00799149
Lead Sponsor
Meir Medical Center
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
75
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
GabapentinGabapentin, Etoricoxib, Sugar pillGabapentin (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.
EtoricoxibGabapentin, Etoricoxib, Sugar pillEtoricoxib (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.
Sugar pillGabapentin, Etoricoxib, Sugar pillSugar 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.
Primary Outcome Measures
NameTimeMethod
1)Pain intensity (as assessed using a 100 visual analog scale) 2)Incidence of dipyrone usage96 hours post-operation
Secondary Outcome Measures
NameTimeMethod
The recovery of functional activity96 hours

Trial Locations

Locations (1)

Meir Medical Center

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Kfar-Saba, Israel

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