Does Optimal Control of Pre-operative Chronic and Acute Pain Predict Improved Function After Orthopedic Surgery?

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. Identifier: NCT00581685
Recruitment Status : Completed
First Posted : December 28, 2007
Last Update Posted : June 11, 2012
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Dr. Colin McCartney, Sunnybrook Health Sciences Centre

December 19, 2007
December 28, 2007
June 11, 2012
January 2008
June 2010   (Final data collection date for primary outcome measure)
Physical function [ Time Frame: 6 weeks postop ]
Same as current
Complete list of historical versions of study NCT00581685 on Archive Site
Pain [ Time Frame: Pre and postoperatively (up to 6 weeks) ]
Same as current
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Does Optimal Control of Pre-operative Chronic and Acute Pain Predict Improved Function After Orthopedic Surgery?
Does Optimal Pain Control With Pregabalin and Celecoxib Predict Improved Function After Total Hip Arthroplasty?
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.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Drug: Pregabalin, Celecoxib
Pregabalin (75mg BID) and Celecoxib(100mg BID) two weeks prior to hip arthroplasty and 3 weeks postoperatively.
Placebo Comparator: 2
Prospective, single center, randomized, double-blinded, placebo controlled study
Intervention: Drug: Pregabalin, Celecoxib
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2010
June 2010   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Dr. Colin McCartney, Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
The Physicians' Services Incorporated Foundation
Not Provided
Sunnybrook Health Sciences Centre
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP