Effects of Pregabalin on Pain After Total Knee Arthroplasty

Condition(s) targeted: Primary Total Knee Arthroplasty

Intervention: Pregabalin 50mg (Drug); Pregabalin 100mg (Drug); Pregabalin 150mg (Drug); Placebo (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Hospital for Special Surgery, New York

Official(s) and/or principal investigator(s):
Jacques T YaDeau, M.D., Ph.D., Principal Investigator, Affiliation: Hospital for Special Surgery, New York

Overall contact:
Carey Ford, B.A., Phone: (212) 774 2602, Email: FordC@hss.edu

Total knee arthroplasty can cause severe postoperative pain, and patients typically receive oral opioid analgesics for over 2 weeks. Side effects of pain management may impair participation in physical therapy and diminish patient satisfaction. Anecdotally, it seems that pregabalin is very helpful to patients after total knee arthroplasty. However, pregabalin can have side effects. It is not clear how much pregabalin to prescribe. Low doses may not be effective, but use of high doses may increase the incidence and severity of side effects. The purpose of this study is to determine which dosage of pregabalin is the most effective at reducing pain after knee surgery.

Official title: Effects of Pregabalin on Pain After Total Knee Arthroplasty: A Randomized, Controlled, Double-Blind Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Postoperative Pain

Secondary outcome:

Opioid-Related Symptom Distress Score

Self-assessed Sedation and Confusion

Numeric Rating Scale (NRS) and Neuropathic Pain

Opioid Usage

Orthopedic Outcomes

Satisfaction

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with osteoarthritis scheduled for primary tricompartmental total knee

arthroplasty with a participating surgeon

- Age 18 to 80 years old

- Planned use of regional anesthesia

- Ability to follow study protocol

- English speaking (primary outcome obtained via telephone call and secondary outcomes

include questionnaires validated in English only)

- Patients planning on being discharged home or to a rehabilitation center that has

agreed to participate

Exclusion Criteria:

- Patients younger than 18 years old and older than 80

- Patients intending to receive general anesthesia

- Allergy or intolerance to one of the study medications

- Patients with an ASA of IV

- Patients with hepatic (liver) failure

- Patients with chronic renal (kidney) failure (Defined as estimated creatinine

clearance < 30 mL/min, based on recommendation that total daily pregabalin dose be reduced to 150 mg with Clcr < 30 mL/min, CLcr=[(140-age (years)] x weight (kg)x0. 85 (for female patients)/[72xserum creatinine (mg/dL)])

- Patients with difficult to manage diabetes mellitus, including insulin-dependence

- Chronic gabapentin/pregabalin use (regular use for longer than 3 months)

- Chronic opioid use (taking opioids for longer than 3 months)

- Patients with major prior ipsilateral open knee surgery.

- Chronic neurontin/lyrica use

Carey Ford, B.A., Phone: (212) 774 2602, Email: FordC@hss.edu

Hospital for Special Surgery, New York, New York 10021, United States; Recruiting
Jacques T YaDeau, M.D., Ph.D., Principal Investigator
Kethy Jules-Elysee, M.D., Sub-Investigator
Enrique Goytizolo, M.D., Sub-Investigator
Spencer Liu, M.D., Sub-Investigator
Devan Bhagat, M.D., Sub-Investigator
Richard Kahn, M.D., Sub-Investigator
Yi Lin, M.D., Sub-Investigator
Douglas Padgett, M.D., Sub-Investigator
Geoffrey Westrich, M.D., Sub-Investigator
David Mayman, M.D., Sub-Investigator
Amar Ranawat, M.D., Sub-Investigator
Michael Alexiades, M.D., Sub-Investigator
Matthew Rade, B.A., Sub-Investigator

Starting date: May 2011
Last updated: September 24, 2012