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NCT01017380 Clinical Trial

Preemptive Analgesia in Cruciate Reconstruction

Anterior Cruciate Ligament Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01017380
Other study ID # EC50/369-007
Secondary ID
Status Completed
Phase Phase 3
First received November 17, 2009
Last updated November 19, 2009
Start date January 2008
Est. completion date June 2009

Study information
Verified date November 2009
Source Prince of Songkla University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date June 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 50 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- previous knee surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Anterior Cruciate Ligament Injury

Intervention

Drug:
• Celecoxib
celecoxib 400 mg 1 cap before surgery
• etoricoxib
120 mg 1 tab before surgery

Locations
Country Name City State
Thailand Prince of Songkla University Hat Yai Songkhla

Sponsors (1)
Lead Sponsor Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary VAS score 6,12,24,48 hour postoperative No
Secondary number of analgesic used 48 hour postoperative No
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