Arthroplasty Inflammation Prophylaxis With Celecoxib
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Postoperative Pain |
Drug: Celecoxib |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Preemptive Anti-Inflammatory Use of Celecoxib in Knee Arthroplasty Surgery: a Double Blinded, Placebo-Controlled Study. |
- Compare total pain rating in group receiving 7day celecoxib against in 1 dose celecoxib
- 1. Comparison of pain rating VRS "When you woke up following surgery," and at 24 hours and 48 hours postoperatively in the two study groups
- Comparison of patient reported maximum pain on VRS in the study groups.
| Estimated Enrollment: | 200 |
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Adam Zanbilowicz, BA DPM MS | 604-885-8803 | zanbilowicz@pol.net |
| Canada, British Columbia | |
| Not yet recruiting | |
| Vancouver, British Columbia, Canada | |
| Contact: Adam Zanbilowicz, BA DPM MS 604-885-8803 zanbilowicz@pol.net | |
| Principal Investigator: | Adam Zanbilowicz, BA DPM MS | Vancouver Coastal Health Authority |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00533247 History of Changes |
| Other Study ID Numbers: | PAC01 |
| Study First Received: | September 20, 2007 |
| Last Updated: | September 20, 2007 |
| Health Authority: | Canada: Health Canada Canada: Ethics Approval by University of BC Office of Research Services |
Keywords provided by Zanbilowicz, Adam, DPM MS:
|
Cox-2 Inhibitor Pre-emptive Pain Preoperative Pain |
Pain Prophylaxis Celebrex Celecoxib |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Celecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on June 18, 2013