A Trial Assessing the Outcome of Celecoxib Administration Versus Placebo Following Anterior Cruciate Ligament (ACL) Reconstruction

Pain Clinical Trial

Official title:

A Trial Assessing the Outcome of Celecoxib Administration Versus Placebo Following Anterior Cruciate Ligament Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01186887
• Other study ID #: 2006-645
• Status: Completed
• Phase: N/A
• First received: March 17, 2010
• Last updated: June 16, 2014
• Start date: February 2009
• Est. completion date: April 2013

Study information

• Verified date: June 2014
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to directly compare the clinical outcomes of both the celecoxib and placebo groups following anterior cruciate ligament (ACL) reconstruction. The study will have short and long term goals. Validated outcome measures will aim to quantify pain control at 2 weeks after surgery, as well as knee function at 2 year follow-up. Groups will be compared using pain control scales, and functional knee outcome scores. The first null hypothesis tested by this study is that the celecoxib group experiences equal pain control compared with the placebo group. The second null hypothesis is that no knee function difference will be found between the celecoxib and placebo groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any patient 18 years and over undergoing primary anterior cruciate ligament reconstruction with hamstring grafts will be considered for this study.

Exclusion Criteria:

• Patients will be excluded if they have bilateral ACL injuries, require revision ACL reconstruction, require meniscus repair, have multiple ligament injuries, gross osteoarthritis, significant clinical malalignment or if they cannot attend appropriate follow-up. Other exclusion criteria will include use of a regional block during the surgery, a diagnosis of esophageal, gastric, or duodenal ulceration, hepatic disease, renal disease, hypertension, hypersensitivity to Celecoxib, known allergic-type reactions to sulfonamides, known allergies to ASA or other NSAIDS, inflammatory bowel disease or hyperkalemia

Study Design

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Celecoxib
The treatment group will receive 400 mg Celecoxib p.o. preoperatively and the control group will receive a placebo between 1 and 3 hours pre-op, when other standard medications are administered. The treatment group will receive 200 mg of Celecoxib orally twice per day post operatively, for a duration of 5 days based on dosing protocols shown to be well tolerated and effective in treating pain following ambulatory surgery. The control group will receive a 5 day supply of placebo pills. Both groups will receive standard post surgical narcotic prescription (Oxycodone IR 5 - 10 mg po qid prn and acetaminophen 325 - 650 mg PO qid prn
• Placebo
The treatment group will receive 400 mg Celecoxib p.o. preoperatively and the control group will receive a placebo between 1 and 3 hours pre-op, when other standard medications are administered. The treatment group will receive 200 mg of Celecoxib orally twice per day post operatively, for a duration of 5 days based on dosing protocols shown to be well tolerated and effective in treating pain following ambulatory surgery. The control group will receive a 5 day supply of placebo pills. Both groups will receive standard post surgical narcotic prescription (Oxycodone IR 5 - 10 mg po qid prn and acetaminophen 325 - 650 mg PO qid prn

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is to test the null hypothesis that Celecoxib perioperatively does not negatively influence the static testing of ACL reconstruction as measured by KT arthrometer at 2 years post op.		2 years	No
Secondary	The 2nd outcome tested by this study is that the celecoxib group experiences equal pain control compared with the placebo group.		2 years	No