COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined

This study has been completed.
Sponsor:
Information provided by:
Asker & Baerum Hospital
ClinicalTrials.gov Identifier:
NCT01361789
First received: May 26, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Rupture of Anterior Cruciate Ligament
Drug: parecoxib, valdecoxib, etoricoxib
Drug: Dexamethasone
Drug: parecoxib, valdecoxib, parecoxib and dexamethasone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined

Resource links provided by NLM:


Further study details as provided by Asker & Baerum Hospital:

Primary Outcome Measures:
  • Postoperative VAS score at rest 24 hours after surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cumulated opioid consumption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 93
Study Start Date: January 2004
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361789

Locations
Norway
Baerum Hospital
Rud, Norway, 1309
Sponsors and Collaborators
Asker & Baerum Hospital
Investigators
Principal Investigator: Vegard Dahl, PhD Baerum Hospital
Principal Investigator: Ulrich J Spreng, MD Baerum Hospital
  More Information

No publications provided

Responsible Party: Baerum Hospital, Vestre Viken HF
ClinicalTrials.gov Identifier: NCT01361789     History of Changes
Other Study ID Numbers: 2004_01927 COX
Study First Received: May 26, 2011
Last Updated: May 26, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency

Keywords provided by Asker & Baerum Hospital:
Arthroscopic reconstruction
Anterior crucial ligament
Coxib
Dexamethasone

Additional relevant MeSH terms:
Dexamethasone acetate
Etoricoxib
Parecoxib
Valdecoxib
Dexamethasone
Dexamethasone 21-phosphate
Glucocorticoids
BB 1101
Cyclooxygenase 2 Inhibitors
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on September 22, 2014