COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined

Rupture of Anterior Cruciate Ligament Clinical Trial

Official title:

COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01361789
• Other study ID #: 2004_01927 COX
• Status: Completed
• Phase: Phase 4
• First received: May 26, 2011
• Last updated: May 26, 2011
• Start date: January 2004
• Est. completion date: December 2009

Study information

• Verified date: May 2011
• Source: Asker & Baerum Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rupture of Anterior Cruciate Ligament

Intervention

Drug:
• 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
8 mg IV
• parecoxib, valdecoxib, parecoxib and dexamethasone
combination of both drugs

Locations

Country	Name	City	State
Norway	Baerum Hospital	Rud

Sponsors (1)

Lead Sponsor	Collaborator
Asker & Baerum Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative VAS score at rest 24 hours after surgery		24 hours	No
Secondary	Cumulated opioid consumption		24 hours	No