Status:
COMPLETED
Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty
Lead Sponsor:
Hospital for Special Surgery, New York
Conditions:
Joint Disease
Pain, Acute
Eligibility:
All Genders
25-75 years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2021
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03271151
Start Date
September 28 2017
End Date
February 19 2021
Last Update
December 27 2024
Active Locations (1)
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1
Hospital for Special Surgery
New York, New York, United States, 10021