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
  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?

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Physical function [ Time Frame: 6 weeks postop ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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).
  Contacts and Locations
No Contacts or Locations Provided
  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 April 16, 2014