Etoricoxib Versus Gabapentin for Knee Arthroscopy

Clalit Health Services

Status and phase: Completed; Phase 4

Conditions: Knee Arthroscopy

Treatments: Drug: Gabapentin, Etoricoxib, Sugar pill

Study type: Interventional

Funder types: Other

Identifiers

NCT00799149

MMC-045-06

Details and patient eligibility

About

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).

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups, including a placebo group

Gabapentin

Active Comparator group

Description:

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.

Treatment:

Drug: Gabapentin, Etoricoxib, Sugar pill

Etoricoxib

Active Comparator group

Description:

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.

Treatment:

Drug: Gabapentin, Etoricoxib, Sugar pill

Sugar pill

Placebo Comparator group

Description:

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.

Treatment:

Drug: Gabapentin, Etoricoxib, Sugar pill