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Can a single pill cut opioid use after hip surgery?

NCT ID NCT06807866

Symptom relief Sponsor: University of Miami Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a single 60 mg dose of duloxetine, given before total hip replacement surgery, can reduce the amount of narcotic painkillers patients need afterward. Researchers will compare duloxetine to a placebo in 64 adults. The goal is to see if this approach leads to better pain control and less reliance on opioids.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
duloxetine
What this could lead to
If it works, this could offer a simple way to reduce opioid use and improve pain control after hip replacement surgery.
What could go wrong
This is a small, early-phase trial with only 64 participants. Duloxetine may not reduce pain or opioid use better than placebo, and it can cause side effects like nausea or dizziness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

THA

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

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