Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty (NCT03271151) | Clinical Trial Compass
CompletedPhase 4
Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty
United States160 participantsStarted 2017-09-28
Plain-language summary
Post-discharge pain after total knee arthroplasty remains problematic; many patients have excessive pain at the 2 week time point (and often thereafter). Reduction in opioid use has become a national goal, due to the 'epidemic' in opioid misuse.
In addition to enrolling non-opioid users, we will enroll up to 15 chronic opioid users.
Who can participate
Age range25 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 25 to 75 years
* Planned use of regional anesthesia
* Ability to follow study protocol
* English speaking (Primary outcome obtained via telephone call and secondary outcomes include questionnaires validated in English only)
* Patients planning on being discharged home or to a rehabilitation center that has agreed to participate
Exclusion Criteria:
* Current Use of duloxetine or other SNRIs, SSRIs, MAOIs, Tricyclic antidepressants, triptans (sumatriptan, rizatriptan, naratriptan, eletriptan, almotriptan, frovatriptan), lithium, buspirone, St. John's Wort
* Hepatic insufficiency
o Hepatoxicity is reported as a side effect of duloxetine. "Median time to detection of transaminase elevation was about two months" (package insert 5.2
* Renal insufficiency (ESRD, HD, estimated creatinine clearance \< 50 ml/min)
* Severe CRI may impair duloxetine clearance
* CLcr=\[(140-age (years)\] x weight (kg)x0.85 (for female patients)/\[72xserum creatinine (mg/dL)\]
* Patients younger than 25 years old and older than 75
* Patients intending to receive general anesthesia
* Allergy or intolerance to one of the study medications
* Patients with an ASA of IV
* Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
* Patients with major prior ipsilateral open knee surgery.
* Chronic opioid use (taking opioids for longer than 3 months)
* However, patients using chronic opioids may enroll in a parallel pilot study entitled 'effect of duloxetine …