Could an antidepressant curb opioid use after knee surgery?
NCT ID NCT06423716
First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times
Summary
This study tests whether the antidepressant duloxetine can help reduce opioid painkiller use after knee replacement surgery. About 150 adults with knee osteoarthritis will receive either duloxetine or a placebo before and after surgery. The goal is to see if duloxetine lowers opioid consumption and improves pain control during recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Duloxetine
- What this could lead to
- If successful, this low-cost medication could reduce opioid use and improve pain control after knee replacement, leading to better recovery and satisfaction.
- What could go wrong
- This is a Phase 4 trial with 150 participants, so results may not apply to everyone. Duloxetine can cause side effects like nausea or dizziness, and it may not significantly reduce opioid consumption.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age \>=50 2. Presence of knee osteoarthritis 3. Planned for elective unilateral total knee arthroplasty 4. ASA I - III 5. 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: 1. Lack of patient consent; unlikely to comply with follow-up 2. 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 3. Chronic and high dose opioid use (\>30mg oral morphine equivalent per day) 4. Substance use disorder (cannabis and related products, alcohol use disorder, opioid used disorder, illicit drugs) 5. Uncontrolled hypertension (systolic BP \> 180mmHg) 6. Untreated psychiatric illness (e.g. depression, suicidal ideation, bipolar disorder) 7. Involved in worker's compensation case/law suit (verbally declared by patient)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sunnybrook Health Sciences Centre
RECRUITINGToronto, Ontario, M4N 3M5, Canada
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Sunnybrook Health Sciences Centre
RECRUITINGToronto, Ontario, M4N 3M5, Canada
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