Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: THA
In brief
The primary objective of this study is to compare total narcotic intake standardized via milligram morphine equivalents between duloxetine and placebo cohorts after a total hip arthroplasty.
Key facts
- Study ID
- NCT06807866
- Run by
- University of Miami
- People needed
- 64
- Starts
- 2025-03-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-03-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients > 18 years of age
- Patients undergoing primary total hip arthroplasty
- Ambulatory patient prior to fracture
- Subjects must be capable of providing informed consent
- English or Spanish speaking
You may not qualify if…
- Previous hemiarthroplasty or THA on ipsilateral hip
- History of Complex Regional Pain Syndrome in ipsilateral extremity
- History of demyelinating disorder or neurologic deficit that may contribute to altered pain tolerance or sensation
- Acute or chronic hip infection in ipsilateral extremity
- Pregnant or breastfeeding
- Open fracture
- Polytrauma
- Intravenous or drug users within 6 months of surgery
- Liver Failure via clinical diagnosis or international normalized ratio greater than 1.5 or partial thromboplastin time greater than 40
- Patients on selective serotonin reuptake inhibitor, serotonin norepinephrine reuptake inhibitor, monoamine oxidase inhibitor, and/or tricyclic anti-depressant
- Severe renal dysfunctions, such as glomerular filtration rate less than 30
- Moderate to severe depression as diagnosed by a clinician
- Taking cytochrome P450 1A2 inhibitors and cytochrome P450 1A6 inhibitors for the duration of 5 half-lives as these drugs are clinically eliminated within 5 half-lives
- History of uncontrolled narrow angle glaucoma
Where it is running
- University of Miami — Miami, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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