Arthroplasty Inflammation Prophylaxis With Celecoxib

NCT00533247 | Unknown DMC

• 1 other identifier: PAC01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain

Keywords

Cox-2 Inhibitor; Pre-emptive Pain; Preoperative Pain; Pain Prophylaxis; Celebrex; Celecoxib

Outcome Measures

Primary Outcomes (1)

• Compare total pain rating in group receiving 7day celecoxib against in 1 dose celecoxib

Secondary Outcomes (2)

• 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.

Interventions

Celecoxib DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy patients undergoing knee arthroplasty

You may not qualify if:

• 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

Sponsors & Collaborators

• Zanbilowicz, Adam, DPM MS: lead

Study Sites (1)

Unknown Facility

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Adam Zanbilowicz, BA DPM MS

  Vancouver Coastal Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Zanbilowicz, BA DPM MS

CONTACT

604-885-8803; zanbilowicz@pol.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: September 20, 2007
• First Posted: September 21, 2007
• Last Updated: September 21, 2007

Record last verified: 2007-09

Locations

CA (1)