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New pain block could replace standard for breast surgery

NCT ID NCT04827030

Symptom relief Sponsor: Institut Curie 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This study tested whether a newer nerve block called ESP works as well as the standard PVB block for pain after breast cancer surgery. 292 women received one of the two blocks before surgery. The main goal was to see how many needed morphine in the first two hours after surgery. The results could help doctors choose a simpler pain control method.

What this could mean

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

Active substance
Ropivacaine (a numbing medicine)
What this could lead to
If ESP works as well as PVB, it could offer a simpler, safer option for controlling pain after breast surgery.
What could go wrong
This is a completed Phase 4 trial, so results are known. The main risk is that ESP may not be as effective as PVB, leading to more pain or morphine use.

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

292 people

The number who actually took part.

Started

Jun 2021

Finished

Jul 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.

Ages

18 to 85 years

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: 1. Woman with breast adenocarcinoma without metastasis or breast in situ adenocarcinoma (with or without breast reconstruction by prosthesis) to by treated: * either by breast-conserving surgery with axillary dissection, * either by modified radical mastectomy with axillary dissection * either by modified radical mastectomy with lymph node dissection * either by modified radical mastectomy without axillary 2. Patients aged between 18 and 85 years old. 3. ASA class 1, 2 or 3 (Physical Status Classification System of American Society of Anesthesiologists (ASA)). 4. Signed informed consent form. 5. Patient able to answer self-assessment questionnaires (sufficient understanding of evaluations and in French). 6. Patient affiliated to the health care insurance. Exclusion Criteria: 1. Preoperative consumption of opioid in the patient's current medications within three months before inclusion. 2. Ipsilateral breast surgery during 3 months prior to the inclusion. 3. Allergy to local anaesthetics and morphine and NSAID. 4. Local skin inflammation at the puncture area. 5. Bilateral breast surgery planned at inclusion. 6. Major immediate ipsilateral breast reconstruction by using tissue flap procedure (example: latissimus dorsi flap, Deep Inferior Epigastric Perforator (DIEP), Transverse Rectus Abdominis Musculocutaneous (TRAM)…). 7. Any contra-indication or patient's refusal for regional anesthesia. 8. Male subjects. 9. Pregnant woman or breastfeeding. 10. B blocker medication. 11. Patient already participating in an analgesia protocol that may interfere with the pain assessment criteria. 12. Patient under legal protection. 13. Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.

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Conditions

The condition(s) this trial relates to.

breast adenocarcinoma breast cancer breast carcinoma in situ

As listed by the trial registrant

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

Breast surgery

Contacts and locations

Locations

  • AP-HP Hôpital Tenon

    Paris, 75970, France

  • Centre Jean Perrin

    Clermont-Ferrand, 63000, France

  • Institut Claudius Régaud UICT

    Toulouse, 31059, France

  • Institut Curie

    Saint-Cloud, 92210, France

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54500, France

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