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New treatment option for Knee Osteoarthritis
Official title Effect of peRiopErative duLoxetIne Administration on Opioid Consumption Following Total kneE Arthroplasty (RELIFE)
ClinicalTrials.gov ID: NCT06423716
What this study is testing
What is Duloxetine?
Duloxetine is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for knee osteoarthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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...
You likely can't join if
- 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)
See the full eligibility 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.
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.