Actively Recruiting
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
Eligibility Criteria
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
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
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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
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
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