NCT06807866 Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT
| NCT ID | NCT06807866 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Miami |
| Condition | THA |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 64 participants in total. It began in 2025-03-01 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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
Contact & Investigator
Victor Hernandez, MD
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT06807866 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying THA. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06807866 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06807866 currently recruiting?
Yes, NCT06807866 is actively recruiting participants. Contact the research team at vhh1@miami.edu for enrollment information.
Where is the NCT06807866 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT06807866 clinical trial?
NCT06807866 is sponsored by University of Miami. The principal investigator is Victor Hernandez, MD at University of Miami. The trial plans to enroll 64 participants.