COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined

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.

Study Overview

• Status: Completed
• Conditions: Rupture of Anterior Cruciate Ligament
• Intervention / Treatment: Drug: parecoxib, valdecoxib, etoricoxib; Drug: Dexamethasone; Drug: parecoxib, valdecoxib, parecoxib and dexamethasone

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Phase 4

Contacts and Locations

Study Locations

• Norway
  • Rud, Norway, 1309
    • Baerum Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: COXIB; 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; 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
Active Comparator: Dexamethasone; dexamethasone 8 mg iv	Drug: Dexamethasone; 8 mg IV
Active Comparator: COXIB and dexamethasone; combination of coxib AND dexamethasone	Drug: parecoxib, valdecoxib, parecoxib and dexamethasone; combination of both drugs

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Cumulated opioid consumption	24 hours

Collaborators and Investigators

• Sponsor: Asker & Baerum Hospital
• Investigators: Principal Investigator: Vegard Dahl, PhD, Baerum Hospital; Principal Investigator: Ulrich J Spreng, MD, Baerum Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: May 26, 2011
• First Submitted That Met QC Criteria: May 26, 2011
• First Posted (Estimate): May 27, 2011

Study Record Updates

• Last Update Posted (Estimate): May 27, 2011
• Last Update Submitted That Met QC Criteria: May 26, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Dexamethasone; Arthroscopic reconstruction; Anterior crucial ligament; Coxib
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Cyclooxygenase 2 Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101; Etoricoxib; Valdecoxib; Parecoxib
• Other Study ID Numbers: 2004_01927 COX