Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT

Use of Duloxetine for Perioperative Pain Control After Total Hip Arthroplasty: Randomized Controlled Clinical Trial (RCT)

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.

Study Overview

• Status: Recruiting
• Conditions: THA
• Intervention / Treatment: Drug: Duloxetine; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Victor Hernandez, MD; Phone Number: 3056895195; Email: vhh1@miami.edu
• Study Contact Backup: Name: Natalia Cruz, MD; Phone Number: 3056895195; Email: nxc971@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Principal Investigator: Victor H Hernandez, MD
      • Contact: Natalia Cruz, MD; Phone Number: 3056895195; Email: nxc971@miami.edu
      • Contact: Ryan Hellinger, BA; Phone Number: 3056895195; Email: rlh147@miami.edu
      • Sub-Investigator: Natalia Cruz, MD
      • Sub-Investigator: Ryan Hellinger, BA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Duloxetine group; Participants will be in this group for up to 2 hours.	Drug: Duloxetine; Participants will come in person and receive a one time 60 mg dose by mouth.
Placebo Comparator: Placebo group; Participants will be in this group for up to 2 hours.	Other: Placebo; Participants will come in person and receive a one time 60 mg placebo pill dose by mouth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Milligram Morphine Equivalent (MME)	The primary outcome measure was milligram morphine equivalent units to measure pain intensity difference and total pain relief	Up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain as measured by Visual Analog Scale (VAS)	The VAS used for pain assessment consists of a line drawn in the form of a ruler, and numbers from 0 to 10 (with 0 as "no pain" and 10 as "unbearable pain") were asked to score.	Baseline, up to 24 hours, 3 months
Musculoskeletal function as measured by SMFA questionnaire	The Short Musculoskeletal Function Assessment Questionnaire (SMFA) consists of 34 questions covering the assessment of the patients function and 12 questions related to how bothered patients are by their symptoms. All categories are scored together, totaling between 0-100 percent. The lower the score, the better the subject's function	Up to 3 months
Hospital Length of stay measured in hours	Hospital Length of stay measured in hours	Up to 96 hours
Ambulation distance measured by meters	Ambulation distance measured by meters	Up to 3 months

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Victor Hernandez, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): February 4, 2025

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiophenes; Duloxetine Hydrochloride
• Other Study ID Numbers: 20240579

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No