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

November 17, 2009
November 19, 2009
January 2008
January 2009   (final data collection date for primary outcome measure)
VAS score [ Time Frame: 6,12,24,48 hour postoperative ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01017380 on ClinicalTrials.gov Archive Site
number of analgesic used [ Time Frame: 48 hour postoperative ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Preemptive Analgesia in Cruciate Reconstruction
Comparing Etoricoxib and Celecoxib for Preemptive Analgesia for Acute Postoperative Pain in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Anterior Cruciate Ligament Injury
  • Drug: Celecoxib
    celecoxib 400 mg 1 cap before surgery
  • Drug: etoricoxib
    120 mg 1 tab before surgery
Experimental: placebo
identical placebo
Interventions:
  • Drug: Celecoxib
  • Drug: etoricoxib
Boonriong T, Tangtrakulwanich B, Glabglay P, Nimmaanrat S. Comparing etoricoxib and celecoxib for preemptive analgesia for acute postoperative pain in patients undergoing arthroscopic anterior cruciate ligament reconstruction: a randomized controlled trial. BMC Musculoskelet Disord. 2010 Oct 25;11:246.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • previous knee surgery
Both
15 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01017380
EC50/369-007
No
Secretariate,Department of Orthopaedic Surgery, Facuty of Medicine, Prince of Songkla University
Prince of Songkla University
Not Provided
Study Director: Boonsin Tangtrakulwanich, MD.,Ph.D Faculty of Medicine, Prince of Songkla University
Prince of Songkla University
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP