Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT

Launched by UNIVERSITY OF MIAMI · Jan 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called duloxetine on pain management after total hip replacement surgery, also known as total hip arthroplasty. The main goal is to see how much pain relief patients get from duloxetine compared to a placebo (a treatment that has no active ingredients) by measuring the total amount of narcotics they need afterward. The trial is currently looking for participants aged 65 to 74 who are able to speak English or Spanish and are planning to undergo this surgery.

To be eligible for the study, participants must be at least 18 years old, have been able to walk before a fracture, and be willing to provide informed consent. However, certain conditions may exclude individuals from participating, such as previous hip surgery on the same side, specific medical histories, or being pregnant or breastfeeding. Those who join the trial can expect to be monitored for their pain levels and medication use in a supportive environment, helping researchers learn more about managing pain effectively after hip surgery.

Gender

ALL

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