Using duloxetine to reduce pain after hip surgery
Use of Duloxetine for Perioperative Pain Control After Total Hip Arthroplasty: Randomized Controlled Clinical Trial (RCT)
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 |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT06807866 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Miami, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.