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Preemptive Analgesia in Cruciate Reconstruction

This study has been completed.
Sponsor:
Information provided by:
Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01017380
First received: November 17, 2009
Last updated: November 19, 2009
Last verified: November 2009
History of Changes
  Purpose

The aims of this study was to compare analgesic efficacy of preoperative administration of etoricoxib versus celecoxib for post-operative pain relief after arthroscopic anterior cruciate ligament reconstruction. One hundred and two patients diagnosed as anterior cruciate ligament injury will randomized into 3 groups using opaque envelope. Both patients and surgeon were blinded to the allocation. All of the patients will be operated by one orthopaedic surgeon under regional anesthesia. Each group will be given either etoricoxib 120 mg., celecoxib 400 mg., or placebo 1 hour prior to operative incision. Post-operative pain intensity, time to first dose of analgesic requirement and numbers of analgesic used for rescue pain control and adverse events will be recorded periodically to 48 hours after surgery.


Condition Intervention Phase
Anterior Cruciate Ligament Injury
 Drug: Celecoxib
Drug: etoricoxib
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing Etoricoxib and Celecoxib for Preemptive Analgesia for Acute Postoperative Pain in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial

Resource links provided by NLM:

Drug Information available for: Celecoxib
U.S. FDA Resources

Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • VAS score [ Time Frame: 6,12,24,48 hour postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of analgesic used [ Time Frame: 48 hour postoperative ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2008
Study Completion Date: June 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: placebo
identical placebo
 Drug: Celecoxib
celecoxib 400 mg 1 cap before surgery
Drug: etoricoxib
120 mg 1 tab before surgery

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with anterior cruciate ligament injury age 15-50 yr

Exclusion Criteria:

  • previous knee surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017380

Locations
Thailand
Prince of Songkla University
Hat Yai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Investigators
Study Director: Boonsin Tangtrakulwanich, MD.,Ph.D Faculty of Medicine, Prince of Songkla University
  More Information

No publications provided by Prince of Songkla University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Secretariate,Department of Orthopaedic Surgery, Facuty of Medicine, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01017380     History of Changes
Other Study ID Numbers: EC50/369-007
Study First Received: November 17, 2009
Last Updated: November 19, 2009
Health Authority: Thailand: Ethical Committee

Keywords provided by Prince of Songkla University:
preemptive analgesia
cruciate ligament

Additional relevant MeSH terms:
Celecoxib
Etoricoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 19, 2013