Actively Recruiting

Phase 4
Age: 50Years +
All Genders
NCT06423716

Effect of peRiopErative duLoxetIne Administration on Opioid Consumption Following Total kneE Arthroplasty (RELIFE)

Led by Sunnybrook Health Sciences Centre · Updated on 2025-12-19

150

Participants Needed

2

Research Sites

112 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Knee replacement surgery for osteoarthritis is a commonly performed procedure in Canada with 75,000 of these surgeries performed each year. Success rate for knee replacement surgery is high but more than 20% of patients are still dissatisfied mainly due to reports of ongoing pain. Pain control following knee surgery is important in order to allow patients to engage in recovery and rehabilitation. The current standard of pain management after surgery centers around the use of opioids which is a concerning practice as highlighted by the opioid epidemic. Duloxetine is an antidepressant that has pain relieving properties and it has been studied in patients undergoing knee replacement surgery. Studies to date have not been designed optimally to demonstrate the full effects of opioid dose reduction and the use of duloxetine as a medication following knee replacement surgery. This research study seeks to start duloxetine before surgery, at the recommended therapeutic dose, and for the duration of the early rehabilitation period. If the study is successful, this low-cost medication can improve satisfaction rates and change the standard way the pain management is typically carried out for patients undergoing the knee replacement surgery.

CONDITIONS

Official Title

Effect of peRiopErative duLoxetIne Administration on Opioid Consumption Following Total kneE Arthroplasty (RELIFE)

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 50 years or older
  • Diagnosed with knee osteoarthritis
  • Scheduled for elective unilateral total knee arthroplasty
  • Classified as ASA physical status I to III
  • Baseline creatinine clearance of 30 mL/min or higher within 60 days before enrollment, or no known kidney disease if test unavailable
Not Eligible

You will not qualify if you...

  • Does not consent or unlikely to follow-up
  • Known allergy to duloxetine or its components
  • History of liver disease such as cirrhosis or non-alcoholic steatohepatitis
  • Uncontrolled narrow-angle glaucoma
  • Severe kidney impairment (creatinine clearance less than 30 mL/min)
  • Taking thioridazine
  • Taking strong CYP1A2 inhibitors like fluvoxamine or certain quinolone antibiotics
  • Using antidepressants including MAOI, SSRI, SNRI, TCA, St. John's Wort, or buspirone
  • Using triptan or lithium medications
  • Chronic high-dose opioid use over 30 mg oral morphine equivalent daily
  • Substance use disorders including cannabis, alcohol, opioids, or illicit drugs
  • Uncontrolled high blood pressure (systolic over 180 mmHg)
  • Untreated psychiatric illnesses such as depression, suicidal thoughts, or bipolar disorder
  • Currently involved in a worker's compensation claim or lawsuit

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

2

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

Loading map...

Research Team

H

Howard Meng, MD

CONTACT

S

Stephen Choi

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here