Effect of peRiopErative duLoxetIne Administration on Opioid Consumption Following Total kneE Arthroplasty (RELIFE)
Key facts
- Phase
- Phase 4
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- Who runs it
- Sunnybrook Health Sciences Centre
- Trial code
- NCT06423716
- Record updated
- 12 August 2026
- Original description
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.Read full original descriptionShow less
Effect of Perioperative Duloxetine Administration on Opioid Consumption Following Total Knee Arthroplasty
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.
Inclusion: Age >=50; Presence of knee osteoarthritis; Planned for elective unilateral total knee arthroplasty; ASA I - III; Baseline creatinine clearance (CrCl) ≥ 30 mL/min within 60 days prior to enrolment, if available. If not available, verbal report from patient of no known renal disease.
Exclusion: Presence of contraindications to study drug use:; Known hypersensitivity to the drug or components of the product; Known liver disease - history of cirrhosis, non-alcoholic steatohepatitis; Uncontrolled narrow - angle glaucoma; Severe renal impairment (CrCl<30mL/min); Concurrent use of thioridazine; Concurrent use of potent CYP1A2 inhibitors (e.g. fluvoxamine) and some quinolone antibiotics (e.g. ciprofloxacin or enoxacin); Concurrent use of antidepressants (e.g. MAOI, SSRI, SNRI, TCA, St. John's Wort, buspirone); Concurrent use of triptan or lithium; Substance use disorder (cannabis and related products, alcohol use disorder, opioid used disorder, illicit drugs); Uncontrolled hypertension (systolic BP \> 180mmHg); Untreated psychiatric illness (e.g. depression, suicidal ideation, bipolar disorder); Lack of patient consent; unlikely to comply with follow-up; Chronic and high dose opioid use (\>30mg oral morphine equivalent per day); Involved in worker's compensation case/law suit (verbally declared by patient).