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NCT06807866PHASE4Recruiting

Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT

University of Miami

Start Date

3/1/2025

Completion Date

12/1/2026

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Interventions

DRUG

Duloxetine

OTHER

Placebo

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Conditions

THA

Locations

University of Miami

Miami, Florida 33136

United States