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Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty

CompletedPhase 4NCT03271151
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty: A Double-blinded Randomized Control Trial
Conditions
Interventions
Sponsor
Hospital for Special Surgery, New York
Start date
2017-09-28
Primary completion
2020-12-03
Sex
All
Age range
from 25 Years to 75 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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 on opioid use after total knee athroplasty among patients exposed to opioids- a pilot study'. The chronic opioid users will be allowed to continue their customary analgesics. The pilot study is otherwise identical to the main study. * This study will enroll up to 15 chronic opioid users. After that, all chronic opioid users are excluded.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03271151