Does Optimal Control of Pre-Operative Chronic and Acute Pain Predict Improved Function After Orthopedic Surgery?
Information source: Sunnybrook Health Sciences Centre
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis
Intervention: Pregabalin, Celecoxib (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Sunnybrook Health Sciences Centre Overall contact:
Colin McCartney, MBChB FRCA FRCPC, Phone: 416-480-6100, Ext: 3230, Email: colin.mccartney@utoronto.ca
Summary
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.
Clinical Details
Official title: Does Optimal Pain Control With Pregabalin and Celecoxib Predict Improved Function After Total Hip Arthroplasty?
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Primary outcome: Physical function
Secondary outcome: Pain
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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).
Locations and Contacts
Colin McCartney, MBChB FRCA FRCPC, Phone: 416-480-6100, Ext: 3230, Email: colin.mccartney@utoronto.ca Additional Information
Starting date: January 2008
Ending date: June 2009
Last updated: January 7, 2008
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