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New device could spot failed pain blocks during mastectomy

NCT ID NCT03832920

Knowledge-focused Sponsor: Institut de Cancérologie de Lorraine Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at 100 women having a mastectomy to see if a device called the Analgesia Nociception Index (ANI) can detect when a nerve block isn't working. The device measures pain signals during general anesthesia. If it works, doctors could adjust pain treatment right away, improving recovery.

What this could mean

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

What this could lead to
If successful, this could help doctors quickly tell if a nerve block is working during breast surgery, leading to better pain control.
What could go wrong
This is a small, observational study, not a treatment trial. The device may not reliably detect block failure in 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.

Participants

100 people

The number who actually took part.

Started

May 2019

Finished

Mar 2023

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.

Who is studied

women undergo for a breast surgery with or without axillary node dissection

Ages

18 years and older

Sex

Female participants only

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: * American Society of Anesthesiologists score (ASA) I or II * Woman * Patients aged over 18 years * BMI between 17 and 30 kg/m2 * Radical mastectomy with or without axillary node dissection. Exclusion Criteria: * Preoperative consumption of opioid * Local Anesthesia allergy * Local skin inflammation at the puncture area * Inability to respond to pain assessment using a Numerical Rating Score (NRS) * Any contra-indication or patient's refusal for regional anesthesia B blocker medication * Pace maker * Inability to perform the PVB (at the appreciation of the anesthesiologist) * Change of surgical procedure other modified radical mastectomy with or without axillary node dissection. * Patient with a severe side effect or who cannot be controlled by additional therapy will be removed from the trial

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • Institut de Cancérologie de Lorraine (ICL)

    Vandœuvre-lès-Nancy, France

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