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Etoricoxib Versus Gabapentin for Knee Arthroscopy

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00799149
Enrollment
75
Registered
2008-11-27
Start date
2006-06-30
Completion date
2007-05-31
Last updated
2008-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Arthroscopy

Keywords

Post-operative pain, Knee arthroscopy, Gabapentin, Etoricoxib, Elective ambulatory knee arthroscopy

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.

Interventions

DRUGGabapentin, 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. .

Sponsors

Meir Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
1)Pain intensity (as assessed using a 100 visual analog scale) 2)Incidence of dipyrone usage96 hours post-operation

Secondary

MeasureTime frame
The recovery of functional activity96 hours

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026