Does Optimal Control of Pre-operative Chronic and Acute Pain Predict Improved Function After Orthopedic Surgery?
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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 3 |
| 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? |
- Physical function [ Time Frame: 6 weeks postop ] [ Designated as safety issue: No ]
- Pain [ Time Frame: Pre and postoperatively (up to 6 weeks) ] [ Designated as safety issue: No ]
| Enrollment: | 31 |
| Study Start Date: | January 2008 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (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:
- Provision of informed consent
- American Society of Anesthesiologists physical status I-III
- Average daily VAS ≥ 4
- Aged 18 - 75 years
- Male or female
- Scheduled for total hip arthroplasty (THA).
Exclusion Criteria:
- Allergy to study medications or local anesthetics
- History of drug or alcohol abuse
- Patients with chronic pain on slow-release preparations of opioid (>30mg morphine equivalent per day)
- Patients with rheumatoid arthritis
- Patients with psychiatric disorders
- Patients unable or unwilling to use Patient Controlled Analgesia (PCA).
- Diabetic patients or those with impaired renal function (Creatinine > 55)
- Obese patients (i.e. BMI > 40).
Contacts and Locations More Information
No publications provided
| Responsible Party: | Dr. Colin McCartney, Staff Anesthesiologist, 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: | June 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Sunnybrook Health Sciences Centre:
|
Chronic pain Preemptive analgesia Pregabalin |
Celecoxib Hip Arthroplasty Osteoarthritis |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Pregabalin Celecoxib Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Anticonvulsants Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Anti-Inflammatory Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on June 18, 2013