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Ear stimulation may soothe Post-Surgery anal pain

NCT ID NCT07659314

Symptom relief Sponsor: University Hospital, Angers 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Updated 3 times

Summary

This study tests whether stimulating the vagus nerve through the ear can reduce pain after anal or rectal surgery. Fifty adults will use a small device twice daily for two weeks before and after surgery. Researchers will track pain levels and painkiller use to see if this simple, non-invasive approach is feasible and helpful.

What this could mean

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

Active substance
transcutaneous electrical nerve stimulator (TENS) applied to the ear
What this could lead to
If it works, this could offer a drug-free way to manage pain after anal or rectal surgery, reducing the need for strong painkillers.
What could go wrong
This is a very early feasibility study with only 50 people. It is not yet proven to work, and the effect may be small or no better than a placebo.

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.

Participants

About 50 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 120 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: * Adult patient * Underwent anal or rectal surgery via the transanal route * Managed on an outpatient basis or in conventional hospitalization * Having signed a consent to participate in the study Exclusion Criteria: * Patient operated on as an emergency * Rectal surgery via abdominal approach or requiring an abdominal approach during the procedure * Known epileptic patient * Patient with a pacemaker * Patient refusing to participate in the study * Pregnant, breastfeeding, or laboring woman * Patient not affiliated with a social security scheme * Person deprived of liberty by judicial or administrative decision * Person subject to compulsory psychiatric care - Any contraindication mentioned in the instructions for use of the medical device under investigation Exclusion Criteria: * Unscheduled conversion from the transanal route to the abdominal route during surgery

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Conditions

The condition(s) this trial relates to.

Pain

As listed by the trial registrant

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

Pain (visceral, somatic, or neuropathic) Rectal surgery Vagal nerve stimulation

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

  • Angers Hospital

    Angers, Maine et Loire, 49933, France

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