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Effects of Pregabalin on Pain After Total Knee Arthroplasty

Information source: Hospital for Special Surgery, New York
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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: Completed

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

Summary

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.

Clinical Details

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

Eligibility

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

Locations and Contacts

Hospital for Special Surgery, New York, New York 10021, United States
Additional Information

Starting date: May 2011
Last updated: March 25, 2015

Page last updated: August 23, 2015

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