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

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Dr. Colin McCartney, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00581685
First received: December 19, 2007
Last updated: June 7, 2012
Last verified: June 2012

December 19, 2007
June 7, 2012
January 2008
June 2010   (final data collection date for primary outcome measure)
Physical function [ Time Frame: 6 weeks postop ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00581685 on ClinicalTrials.gov Archive Site
Pain [ Time Frame: Pre and postoperatively (up to 6 weeks) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
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).
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00581685
216-2007, PSI-07-52
No
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