COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined

Asker & Baerum Hospital

Status and phase: Completed; Phase 4

Conditions: Rupture of Anterior Cruciate Ligament

Treatments: Drug: Dexamethasone; Drug: parecoxib, valdecoxib, etoricoxib; Drug: parecoxib, valdecoxib, parecoxib and dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT01361789

2004_01927 COX

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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93 participants in 3 patient groups

COXIB

Active Comparator group

Description:

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

Treatment:

Drug: parecoxib, valdecoxib, etoricoxib

Dexamethasone

Active Comparator group

Description:

dexamethasone 8 mg iv

Treatment:

Drug: Dexamethasone

COXIB and dexamethasone

Active Comparator group

Description:

combination of coxib AND dexamethasone

Treatment:

Drug: parecoxib, valdecoxib, parecoxib and dexamethasone