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

NCT00581685 | Completed Phase 3

• 2 other identifiers: 216-2007PSI-07-52
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Osteoarthritis

Keywords

Chronic pain; Preemptive analgesia; Pregabalin; Celecoxib; Hip Arthroplasty; Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Physical function

  6 weeks postop

Secondary Outcomes (1)

• Pain

  Pre and postoperatively (up to 6 weeks)

Study Arms (1)

2

PLACEBO COMPARATOR

Prospective, single center, randomized, double-blinded, placebo controlled study

Drug: Pregabalin, Celecoxib

Interventions

Pregabalin, Celecoxib DRUG

Pregabalin (75mg BID) and Celecoxib(100mg BID) two weeks prior to hip arthroplasty and 3 weeks postoperatively.

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• The Physicians' Services Incorporated Foundation: collaborator

MeSH Terms

Conditions

Osteoarthritis; Chronic Pain

Interventions

Pregabalin; Celecoxib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 28, 2007
• Study Start: January 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 11, 2012

Record last verified: 2012-06