COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined

Phase 4

Completed

• Conditions: Rupture of Anterior Cruciate Ligament
• Interventions: Drug: parecoxib, valdecoxib, etoricoxib; Drug: Dexamethasone; Drug: parecoxib, valdecoxib, parecoxib and dexamethasone

• Registration Number: NCT01361789
• Lead Sponsor: Asker & Baerum Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2011-05
• Study First Submitted: 2011-05-26
• Study First Submitted QC: 2011-05-26
• Last Update Submitted: 2011-05-26
• Study First Posted: 2011-05-27
• Last Update Posted: 2011-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

• Arthroscopic reconstruction of the anterior crucial ligament (ACL)
• At least 18 years old
• ASA I + II

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Exclusion Criteria

• Known renal impairment
• Liver failure and/-or an asthmatic condition
• Pregnancy
• Breast feeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COXIB	parecoxib, valdecoxib, etoricoxib	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
Dexamethasone	Dexamethasone	dexamethasone 8 mg iv
COXIB and dexamethasone	parecoxib, valdecoxib, parecoxib and dexamethasone	combination of coxib AND dexamethasone

Primary Outcome Measures

Name	Time	Method
Postoperative VAS score at rest 24 hours after surgery	24 hours

Secondary Outcome Measures

Name	Time	Method
Cumulated opioid consumption	24 hours

Trial Locations

Locations (1)

Baerum Hospital; 🇳🇴 Rud, Norway