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Arthroplasty Inflammation Prophylaxis With Celecoxib

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2007 by Zanbilowicz, Adam, DPM MS.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00533247
First Posted: September 21, 2007
Last Update Posted: September 21, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Zanbilowicz, Adam, DPM MS
  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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Preemptive Anti-Inflammatory Use of Celecoxib in Knee Arthroplasty Surgery: a Double Blinded, Placebo-Controlled Study.

Resource links provided by NLM:


Further study details as provided by Zanbilowicz, Adam, DPM MS:

Primary Outcome Measures:
  • Compare total pain rating in group receiving 7day celecoxib against in 1 dose celecoxib

Secondary Outcome Measures:
  • 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533247


Contacts
Contact: Adam Zanbilowicz, BA DPM MS 604-885-8803 zanbilowicz@pol.net

Locations
Canada, British Columbia
Not yet recruiting
Vancouver, British Columbia, Canada
Contact: Adam Zanbilowicz, BA DPM MS    604-885-8803    zanbilowicz@pol.net   
Sponsors and Collaborators
Zanbilowicz, Adam, DPM MS
Investigators
Principal Investigator: Adam Zanbilowicz, BA DPM MS Vancouver Coastal Health
  More Information

ClinicalTrials.gov Identifier: NCT00533247     History of Changes
Other Study ID Numbers: PAC01
First Submitted: September 20, 2007
First Posted: September 21, 2007
Last Update Posted: September 21, 2007
Last Verified: September 2007

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
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents


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