Arthroplasty Inflammation Prophylaxis With Celecoxib

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This double blinded, placebo controlled, study seeks to determine the efficacy of preoperative anti-inflammatory therapy on the reduction of postoperative pain in knee arthroplasty surgery. Pre-emptive use of NSAIDS has demonstrated only modest reduction in post-operative pain in previous studies. However, the short duration of dosing in those studies did not capitalized on the anti-inflammatory properties of NSAIDS. Short-term use of NSAIDS only provides pain relief and does not address inflammation. Traditional NSAIDS cannot be used preoperatively due to platelet effects. Celecoxib, however, is both an analgesic and anti-inflammatory, but does not interfere with bleeding. It can therefore be safely used before surgery. This study hypothesizes that the use of celecoxib for seven days preoperatively reduces postoperative inflammation and consequently pain. A detailed Medline search has not identified any studies into the preoperative use of an NSAID at a dosing level that achieves anti-inflammatory effects.If effective in reducing postoperative pain, this research could lead to a new understanding of the role inflammation plays in orthopedic procedures and other elective procedures and thus improve patient outcomes in the future.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Zanbilowicz, Adam, DPM MS
• Treatments: Celecoxib

Criteria

Inclusion Criteria:

• Healthy patients undergoing knee arthroplasty

Exclusion Criteria:

Subjects will be excluded from the study for the following reasons:

• Allergy to non-steroidal anti-inflammatory medications

• Subjects must not be taking another NSAID while the study is conducted

• Bleeding disorder

• Impaired renal function (serum creatinine >1.2 x upper limit of normal)

• Liver Disease (SGPT(ALT) or SGOT(AST) > 1.5x upper limit of normal)

• Heart Disease

• Ulcers

• Taking an ACE inhibitor

• Taking a diuretic

• Must not be taking an NSAID on a daily basis during the study period

• Pregnant or planning to start a pregnancy soon