Using duloxetine to reduce pain after hip surgery
Official title: Use of Duloxetine for Perioperative Pain Control After Total Hip Arthroplasty: Randomized Controlled Clinical Trial (RCT)
Run by University of Miami · NCT06807866 · Data updated 2026-11-12
This study is testing if the medication duloxetine can help people who have had hip surgery use less pain medication during their recovery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 64 (estimated) |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | December 1, 2026 |
| Study ends | December 1, 2026 |
| Registry record updated | March 18, 2026 |
| Trial ID | NCT06807866 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old who are scheduled for primary total hip arthroplasty and were ambulatory prior to their condition.
✕Probably not a fit
Patients with a history of certain neurological disorders, previous hip surgeries, or those currently on specific antidepressants may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of duloxetine in reducing total narcotic intake, measured in milligram morphine equivalents, compared to a placebo in patients undergoing total hip arthroplasty. It involves administering duloxetine or a placebo to participants and monitoring their pain management needs post-surgery. The goal is to determine if duloxetine can help minimize reliance on narcotics during recovery from hip surgery.
Why it matters
Potential benefit: If successful, this could lead to improved pain management strategies for patients undergoing hip arthroplasty, potentially reducing the need for narcotics.
How similar studies have gone: Other studies have explored the use of duloxetine for pain management, indicating potential benefits, but this specific application in perioperative settings is less commonly tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of Miami
Miami, Florida, United States Recruiting
Study contacts
- Principal investigator: Victor Hernandez, MD — University of Miami
- Study coordinator: Victor Hernandez, MD
- Email: vhh1@miami.edu
- Phone: 3056895195
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.