MIRs 04 : Interpectoral Nerve Block With Ropivacaine Versus Placebo Before Breast Cancer Surgery

Last updated: September 15, 2025
Sponsor: Institut Curie
Overall Status: Completed

Phase

3

Condition

Breast Cancer

Neoplasms

Treatment

Saline

Ropivacaine

Clinical Study ID

NCT04327063
IC 2019-04
  • Ages 18-85
  • Female

Study Summary

Compare the effect of ropivacaine versus placebo pectoral nerve block (Pecs 1 and 2) on acute pain after tumorectomy plus sentinel lymph node dissection on one day surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Women with non-metastatic invasive breast carcinoma or breast carcinoma in situtreated by breast-conserving surgery (tumorectomy) with sentinel node technique onone day surgery.

  2. Age between 18 and 85 years.

  3. ASA class 1, 2 or 3

  4. Signed informed consent form.

Exclusion

Exclusion Criteria:

  1. Ongoing neoplasm or history of neoplasm other than breast cancer with the exceptionof: basal cell carcinoma, cervical carcinoma in situ, other treated cancer that hasnot relapsed during the 5 years preceding inclusion in the trial.

  2. Axillary dissection planned during surgery planning

  3. All bilateral surgery the day of Pecs administration

  4. Metastatic breast carcinoma at diagnosis (M1).

  5. Allergy to local anesthetics and morphine.

  6. Use of analgesics during the 12 hours preceding the surgical procedure.

  7. History of ipsilateral surgery during the previous 6 months.

  8. History of substance abuse.

  9. Pregnant woman or breastfeeding.

  10. Subjects deprived of their liberty or under guardianship (including temporaryguardianship).

  11. Subjects no covered by social security scheme

  12. Experiencing any psychiatric condition or major cognitive impairment that may hampercompletion of self-reported questionnaires.

There is no prohibition for people to take part simultaneously in another search and there is no exclusion cause at the end of the research period

Study Design

Total Participants: 182
Treatment Group(s): 2
Primary Treatment: Saline
Phase: 3
Study Start date:
August 04, 2020
Estimated Completion Date:
January 28, 2022

Study Description

Before surgery, the 3rd interpectoral space will be identified. After aspiration, half of the solution of Ropivacaine 5 mg/ml not exceeding 3 mg/kg of maximal dose and 30 ml of maximal volume or saline (not exceeding 30 ml of maximal volume) will be injected into the interpectoral space underneath the pectoralis major muscle for the Pecs 1 block. The other half of the solution will be injected above the serratus anterior muscle at the third rib.

Evaluation of the percentage of patients treated with step 2 or 3 analgesics during the three postoperative hours.

Connect with a study center

  • Centre Jean Perrin

    Clermont-Ferrand, 63000
    France

    Site Not Available

  • Centre Jean Perrin

    Clermont-Ferrand 3024635, 63000
    France

    Site Not Available

  • Hopital Tenon

    Paris, 75020
    France

    Site Not Available

  • Institut Curie

    Paris, 75005
    France

    Site Not Available

  • Hopital Tenon

    Paris 2988507, 75020
    France

    Site Not Available

  • Institut Curie

    Paris 2988507, 75005
    France

    Site Not Available

  • Institut de Cancérologie de Lorraine

    Vandoeuvre les Nancy, 54500
    France

    Site Not Available

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy 2970797, 54500
    France

    Site Not Available

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