Etoricoxib Versus Gabapentin for Knee Arthroscopy | RxWiki

Etoricoxib Versus Gabapentin for Knee Arthroscopy

Overview[ - collapse ][ - ]

Purpose	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).
Condition	Knee Arthroscopy
Intervention	Drug: Gabapentin, Etoricoxib, Sugar pill
Phase	Phase 4
Sponsor	Meir Medical Center
Responsible Party	Meir Medical Center
ClinicalTrials.gov Identifier	NCT00799149
First Received	November 26, 2008
Last Updated	November 26, 2008
Last verified	November 2008

Tracking Information[ + expand ][ + ]

First Received Date	November 26, 2008
Last Updated Date	November 26, 2008
Start Date	June 2006
Estimated Primary Completion Date	May 2007
Current Primary Outcome Measures	1)Pain intensity (as assessed using a 100 visual analog scale) 2)Incidence of dipyrone usage [Time Frame: 96 hours post-operation] [Designated as safety issue: Yes]
Current Secondary Outcome Measures	The recovery of functional activity [Time Frame: 96 hours] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Etoricoxib Versus Gabapentin for Knee Arthroscopy
Official Title	Phase 4 Study Comparing the Efficacy of Etoricoxib Versus Gabapentin as Part of a Multimodal Analgesic Regimen for 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.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Knee Arthroscopy
Intervention	Drug: Gabapentin, 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. .
Study Arm (s)	Active Comparator: Gabapentin 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. Active Comparator: Etoricoxib 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. Placebo Comparator: Sugar pill 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.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	75
Estimated Completion Date	May 2007
Estimated Primary Completion Date	May 2007
Eligibility Criteria	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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Israel

Administrative Information[ + expand ][ + ]

NCT Number	NCT00799149
Other Study ID Numbers	MMC-045-06
Has Data Monitoring Committee	No
Information Provided By	Meir Medical Center
Study Sponsor	Meir Medical Center
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	November 2008

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