Recruiting

Duloxetine

Sponsor:

University of Miami

Code:

NCT06807866

Conditions

THA

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Duloxetine

Placebo

Study Details

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

Study ID

NCT06807866

Start date

Mar 1, 2025

Status verified date

Mar, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Duloxetine group

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

placebo comparator: Placebo group

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

Interventions

Duloxetine

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

Placebo

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

Primary outcome measure

  • Total Milligram Morphine Equivalent (MME) [ Time Frame: Up to 24 hours ]

Central Contacts and Locations

Central contacts

Victor Hernandez, MD

3056895195vhh1@miami.edu

Natalia Cruz, MD

3056895195nxc971@miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Natalia Cruz, MD

3056895195nxc971@miami.edu

Ryan Hellinger, BA

3056895195rlh147@miami.edu

Principal Investigator:

Victor H Hernandez, MD

More Information

Sponsor

University of Miami

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-03-18.