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One shot vs. catheter: which controls pain better after leg fracture surgery?

NCT ID NCT07221019

Symptom relief Sponsor: George Washington University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 injection of a long-acting anesthetic (Exparel) can control pain as well as a catheter that delivers continuous anesthetic after leg fracture surgery. Ninety adults with closed leg fractures will receive either the single shot or the catheter before surgery, and their pain and opioid use will be tracked for 72 hours. The goal is to find a simpler, effective way to manage pain and reduce 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
bupivacaine (Exparel) and ropivacaine
What this could lead to
If Exparel works as well as catheters, it could simplify pain management after leg fracture surgery and reduce the need for opioid painkillers.
What could go wrong
This is a small, early-phase study (90 people) comparing two existing approaches, so it may not show a clear advantage. Individual pain responses vary, and results may not apply to all patients.

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 90 people

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

Started

Sep 2025

Expected to finish

Aug 2029

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: * Closed lower extremity orthopedic injury * Opioid naive patients * No other significant surgical injuries on admission as determined by study physician Exclusion Criteria: * Allergy to local anesthetics * Multiple traumatic injuries * Weight less than 60 kg * Prior opioid use or risk of increased pain control needs as determined by PI * Chronic opioid use * Open fractures * Plastic surgery needed for complete closure * Patient has intraoperative cardiac arrest

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Conditions

The condition(s) this trial relates to.

bone fracture Femoral Fractures

As listed by the trial registrant

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

Fracture Fracture dislocation of ankle joint Fracture femur Fracture leg Fracture lower leg

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

  • The George Washington University Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20037, United States

More trials for these conditions

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