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| Sponsor: | Sunnybrook Health Sciences Centre |
|---|---|
| Collaborator: |
The Physicians' Services Incorporated Foundation |
| Information provided by: | Sunnybrook Health Sciences Centre |
| ClinicalTrials.gov Identifier: | NCT00581685 |
Purpose
Despite the development of new pain medications, the prevalence of persistent postoperative pain (for more than three to six months) remains alarmingly high. Chronic pain and reduced function after surgery are of great concern since they have a significant impact on a patient's quality of life and are costly to society in terms of longer hospital stays and lost work days. An important risk factor for chronic pain and reduced function after surgery is the amount of pain patients experience immediately after surgery which is highly influenced by the amount of pain patients have preoperatively. For many patients, longstanding pain prior to surgery is common and thus can compromise the outcome of the procedure. Therefore, the aim of this study is to reduce the amount of pain patients have before they undergo surgery by administering a novel pain-relieving regimen in the weeks before surgery. Crucially, this treatment will be continued for three weeks after surgery to reduce pain that arises from the surgical trauma. The novel regimen will include a non-steroidal anti-inflammatory (celecoxib) and the alpha2 delta ligand, pregabalin. This drug combination will provide the best opportunity to target several key sites in the pain pathway. This regimen will be tested in patients with pain related to osteoarthritis and who are undergoing orthopedic (hip) surgery because chronic preoperative pain is common in these patients and is the main reason for undergoing surgery. The goal of this research proposal is to adequately manage pain before and after surgery in order to improve function weeks after surgery. If controlling pain in this way does lead to improved long term postoperative function the findings from this study may lead to the development of a standardized regimen. This is highly relevant not only for orthopedic procedures but following other common surgical procedures which would be of great benefit to patients and the entire healthcare system.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Drug: Pregabalin, Celecoxib |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Does Optimal Pain Control With Pregabalin and Celecoxib Predict Improved Function After Total Hip Arthroplasty? |
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 2
Prospective, single center, randomized, double-blinded, placebo controlled study
|
Drug: Pregabalin, Celecoxib
Pregabalin (75mg BID) and Celecoxib(100mg BID) two weeks prior to hip arthroplasty and 3 weeks postoperatively.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Colin McCartney, MBChB FRCA FRCPC | 416-480-6100 ext 3230 | colin.mccartney@utoronto.ca |
| Contact: Nicole Carmichael, Ph.D | 416-967-8600 ext 8518 | nicole.carmichael@utoronto.ca |
More Information
| Responsible Party: | Dr. Colin McCartney, Sunnybrook Health Sciences Centre |
| ClinicalTrials.gov Identifier: | NCT00581685 History of Changes |
| Other Study ID Numbers: | 216-2007, PSI-07-52 |
| Study First Received: | December 19, 2007 |
| Last Updated: | January 6, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Chronic pain Preemptive analgesia Pregabalin |
Celecoxib Hip Arthroplasty Osteoarthritis |
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Celecoxib Pregabalin 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 Anticonvulsants |