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Ear acupuncture aimed at cutting opioid use after broken leg surgery – but trial never started

NCT ID NCT05984433

Symptom relief Sponsor: Baylor College of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study planned to test whether adding ear acupuncture to standard pain management could reduce opioid use after surgery for lower leg fractures. It was designed for adults aged 18–64 undergoing ankle or foot fracture repair. However, the trial was withdrawn before enrolling any participants, so no data were collected.

What this could mean

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

Active substance
Auricular acupuncture (electro acupuncture device)
What this could lead to
If it had worked, this could point toward a way to reduce opioid use after leg fracture surgery, lowering the risk of addiction and side effects.
What could go wrong
The trial was withdrawn before any participants were enrolled, so no results are available. Even if conducted, the effect of acupuncture on opioid use is uncertain and may vary by individual.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Expected to start

Dec 2025

An estimate. Start dates often move.

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 to 64 years

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: 1. Patient ages 18-64 2. American Society of Anesthesiology Physical Status I, II or III 3. Inpatients scheduled to undergo ankle ORIF at Harris Health System Ben Taub Hospital Exclusion Criteria: 1. Renal dysfunction (Serum Cr \> 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications 2. Allergy to any of the standard anesthetic agents 3. Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder) 4. Patient or surgeon refusal

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Conditions

The condition(s) this trial relates to.

Ankle Fractures Pain, Postoperative tibia fracture

As listed by the trial registrant

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

Foot fracture Fracture, ankle Pain, postoperative Pilon fracture of tibia

Contacts and locations

Locations

  • Ben Taub Hospital

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.