Effect of peRiopErative duLoxetIne Administration on Opioid Consumption Following Total kneE Arthroplasty (RELIFE)
Recruiting · NCT06423716 · Interventional (participants receive a specific treatment) · Lead sponsor: Sunnybrook Health Sciences Centre
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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 criteria
- Lack of patient consent; unlikely to comply with follow-up
- 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
- Chronic and high dose opioid use (\>30mg oral morphine equivalent per day)
- 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)
- Involved in worker's compensation case/law suit (verbally declared by patient)
Where it is running
2 locations listed.
- Sunnybrook Health Sciences Centre - Toronto, Ontario, Canada
- Sunnybrook Health Sciences Centre - Toronto, Ontario, Canada