Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06807866

Duloxetine for Perioperative Pain in Hip Arthroplasty: A 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

THA

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Natalia Cruz, MD

CONTACT

[email protected]

3056895195

Natalia Cruz, MD

SUB_INVESTIGATOR

Ryan Hellinger, BA

CONTACT

[email protected]

3056895195

Ryan Hellinger, BA

SUB_INVESTIGATOR

Victor H Hernandez, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duloxetine

Drug

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

Placebo

Other

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

Primary outcomes

  1. Total Milligram Morphine Equivalent (MME)

    Time frame: Up to 24 hours

    The primary outcome measure was milligram morphine equivalent units to measure pain intensity difference and total pain relief

Secondary outcomes

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

    Time frame: Baseline, up to 24 hours, 3 months

    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.

  2. Musculoskeletal function as measured by SMFA questionnaire

    Time frame: Up to 3 months

    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

  3. Hospital Length of stay measured in hours

    Time frame: Up to 96 hours

    Hospital Length of stay measured in hours

  4. Ambulation distance measured by meters

    Time frame: Up to 3 months

    Ambulation distance measured by meters

Study contacts

Contact information is provided by the study sponsor or research team.

Natalia Cruz, MD

CONTACT

[email protected]

3056895195

Victor Hernandez, MD

CONTACT

[email protected]

3056895195

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.