Perioperative duloxetine to reduce opioid use after knee replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled Phase 4 trial will assign adults having elective unilateral total knee arthroplasty to receive either 60 mg duloxetine daily starting two weeks before surgery or matching placebo alongside standard analgesic care. The primary outcome is cumulative opioid consumption over the first postoperative week, and secondary outcomes include nausea/vomiting and discharge readiness. Investigators will collect opioid use and patient-reported outcomes during the perioperative period and follow standardized prescribing and analgesia protocols. The design addresses limitations of earlier trials by using the recommended 60 mg dose and initiating therapy preoperatively for a longer duration.

Why it matters

Who can join: the full rules

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 (\&gt;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 \&gt; 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)

Where it's running

• Sunnybrook Health Sciences Centre
  Toronto, Ontario, Canada Recruiting
• Sunnybrook Health Sciences Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Howard Meng, MD
• Email: howard.meng@sunnybrook.ca
• Phone: 416-480-4864

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.