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Preemptive Analgesia in Cruciate Reconstruction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01017380
First Posted: November 20, 2009
Last Update Posted: November 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Prince of Songkla University
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • VAS score [ Time Frame: 6,12,24,48 hour postoperative ]

Secondary Outcome Measures:
  • number of analgesic used [ Time Frame: 48 hour postoperative ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: November 17, 2009
First Posted: November 20, 2009
Last Update Posted: November 20, 2009
Last Verified: November 2009

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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents