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

NCT01186887 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-06-17

No results posted yet for this study

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.

Conditions

Interventions

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

DRUG

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Geoff Dervin, MD · The Ottawa Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01186887 on ClinicalTrials.gov