COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined

Study Overview
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Brief Summary
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Recent studies on molar surgery have shown that a combination of a glucocorticoid and NSAID or COX-2 selective inhibitor gives better pain relief than either of the drugs used separately. The investigators group has also shown that adding dexamethasone on top of a regimen of paracetamol, NSAID and local anesthesia resulted in 45% painfree patients at rest after ambulatory breast cancer surgery. The goal of this study is to test the NSAID + glucocorticoid concept in ACl repair. The investigators want to evaluate whether a selective COX-2 selective inhibitor or a glucocorticoid or a combination of both drugs, as part of a multimodal analgesic regime, can provide improved pain relief and shorter hospital stay in patients undergoing outpatient ACL surgery.

Official Title
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COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined

Conditions
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Rupture of Anterior Cruciate Ligament

Intervention / Treatment
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* Drug: parecoxib, valdecoxib, etoricoxib
* Drug: Dexamethasone
* Drug: parecoxib, valdecoxib, parecoxib and dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Arthroscopic reconstruction of the anterior crucial ligament (ACL) At least 18 years old ASA I + II Exclusion Criteria: Known renal impairment Liver failure and/-or an asthmatic condition Pregnancy Breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: COXIB<br>40 mg parecoxib (Dynastat, Pfizer®) one hour before surgery and 40 mg valdecoxib (prodrug of parecoxib, Bextra, Pfizer®)were given 8 hour after surgery. After retraction of parecoxib from the market: Etoricoxib (Arcoxia, MSD) 120 mg given one hour before surgery | Drug: parecoxib, valdecoxib, etoricoxib<br>* 40 mg parecoxib (Dynastat, Pfizer®) one hour before surgery and 40 mg valdecoxib (prodrug of parecoxib, Bextra, Pfizer®)were given 8 hour after surgery. After retraction of parecoxib from the market: Etoricoxib (Arcoxia, MSD) 120 mg given one hour before surgery<br>|
| Active Comparator: Dexamethasone<br>dexamethasone 8 mg iv | Drug: Dexamethasone<br>* 8 mg IV<br>|
| Active Comparator: COXIB and dexamethasone<br>combination of coxib AND dexamethasone | Drug: parecoxib, valdecoxib, parecoxib and dexamethasone<br>* combination of both drugs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative VAS score at rest 24 hours after surgery |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulated opioid consumption |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroscopic reconstruction, Anterior crucial ligament, Coxib, Dexamethasone