Effect of Celecoxib Versus Placebo Before and After Knee Surgery on Overall Use of Analgesics After Surgery

Study Overview
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Brief Summary
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To compare total analgesic use at 24 hours after arthroscopic knee surgery in celecoxib-treated versus placebo-treated patients

Official Title
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A Double-Blind, Placebo-Controlled, Randomized Comparison Study of the Efficacy of Celebrex 400 mg Single Dose Pre and Celebrex 200 mg Post Ambulatory Arthroscopic Knee Surgery for Total Analgesic Use After Surgery

Conditions
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Arthroscopy

Intervention / Treatment
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* Other: Placebo
* Drug: Celecoxib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria: Diagnosed (or suspected to have) meniscus trauma of the knee requiring ambulatory arthroscopic knee surgery Willing to participate in study for 36 hours and come to follow-up visit 7 days post surgery Exclusion Criteria: Exclusion criteria: Osteoarthritis, inflammatory arthritis, or previous fracture of index joint Received acetaminophen or low dose narcotic (vicodin/tylox) within 8 hours of surgery Have received oral (4 weeks), intramuscular (2 months), intra-articular (3 months) or soft-tissue (2 months) injections of corticosteroids of the first dose of study medication or intra-artcular injections of hyaluronic acid in the index joint within 9 months of the first dose of study medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: B<br> | Other: Placebo<br>* Matched oral capsule administered 1 hour prior to surgery and matched oral capsule administered post surgery as needed<br>|
| Experimental: A<br> | Drug: Celecoxib<br>* 400 mg oral capsule as single dose administered 1 hour prior to surgery and 200 mg oral capsule as single dose administered post surgery as needed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total analgesic use (hydrocodone bitartrate 5 mg/acetaminophen 500 mg [HC/APAP]) after surgery |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Assessment of Pain, according to visual analogue scale, after surgery at rest and flexion |  | 1, 2, 6, 8, 10, 12, 24, 36 hours | 
| Time to analgesic use after surgery |  | 1, 2, 6, 8, 10, 12, 24, 36 hours | 
| Number and percentage of patients taking HC/APAP after surgery |  | 1, 2, 6, 8, 10, 12, 24, 36 hours | 
| Adverse events |  | Day 7 | 
| Physical exam |  | Day 7 | 
| Vital signs |  | Day 7 | 
| Laboratory evaluation |  | Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee Surgery Arthroscopic Surgery