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OpenTrials
Completed

NCT Number: NCT00799149

Etoricoxib Versus Gabapentin for 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).

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Key information

Conditions

Knee Arthroscopy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Meir Medical Center

Kfar Saba, 44281, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gabapentin, Etoricoxib, Sugar pill

Drug

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. .

Primary outcomes

  1. 1)Pain intensity (as assessed using a 100 visual analog scale) 2)Incidence of dipyrone usage

    Time frame: 96 hours post-operation

Secondary outcomes

  1. The recovery of functional activity

    Time frame: 96 hours

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 27, 2008
Registry last updated
Nov 27, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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