Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT

NCT06807866 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 20240579
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

THA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Pain as measured by Visual Analog Scale (VAS)

  Baseline, up to 24 hours, 3 months

• Musculoskeletal function as measured by SMFA questionnaire

  Up to 3 months

• Hospital Length of stay measured in hours

  Up to 96 hours

• Ambulation distance measured by meters

  Up to 3 months

Study Arms (2)

Duloxetine group

EXPERIMENTAL

Participants will be in this group for up to 2 hours.

Drug: Duloxetine

Placebo group

PLACEBO COMPARATOR

Participants will be in this group for up to 2 hours.

Other: Placebo

Interventions

Duloxetine DRUG

Participants will come in person and receive a one time 60 mg dose by mouth.

Duloxetine group

Placebo OTHER

Participants will come in person and receive a one time 60 mg placebo pill dose by mouth.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Interventions

Duloxetine Hydrochloride

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Victor Hernandez, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victor Hernandez, MD

CONTACT

3056895195; vhh1@miami.edu

Natalia Cruz, MD

CONTACT

3056895195; nxc971@miami.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)