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

NCT04327063 | Completed Phase 3

• 1 other identifier: IC 2019-04
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Malignant Neoplasm of Breast

Keywords

Surgery conservative; Nerve block

Outcome Measures

Primary Outcomes (1)

• To 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

  Percentage of patients treated with step 2 or 3 analgesics during the first three postoperative hours after tumorectomy plus sentinel lymph node dissection, between the group with Ropivacaïne and the group with placebo

  3 hours

Secondary Outcomes (8)

• Evaluation of acute pain at rest and after shoulder movement until 48 postoperative hours

  48 hours

• Evaluation of acute pain until 48 postoperative hours

  48 hours

• Evaluation of patient's satisfaction on pain management

  48 hours

• Evaluation of Remifentanil consumption during anesthesia

  3 hours

• Evaluation of analgesic consumption during the first 48 postoperative hours

  48 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Saline (30 mL maximum)

Drug: Saline

Ropivacaïne

EXPERIMENTAL

Ropivacaïne 5 mg/mL (not to exceed 3 mg/kg and 30 ml of maximal volume)

Drug: Ropivacaine

Interventions

Saline DRUG

Injection of the solution of Saline not exceeding 30 mL of maximal volume.

Also known as: NA Cl 0.9%

Placebo

Ropivacaine DRUG

Dilution of Ropivacaine 7.5 mg/ml to 5 mg/ml not to exceed 3 mg/kg of maximal dose and 30 ml of maximal volume

Also known as: Naropeine

Ropivacaïne

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with non-metastatic invasive breast carcinoma or breast carcinoma in situ treated by breast-conserving surgery (tumorectomy) with sentinel node technique on one day surgery.
• Age between 18 and 85 years.
• ASA class 1, 2 or 3
• Signed informed consent form.

You may not qualify if:

• Axillary dissection planned during surgery planning
• All bilateral surgery the day of Pecs administration
• Metastatic breast carcinoma at diagnosis (M1).
• Allergy to local anesthetics and morphine.
• Use of analgesics during the 12 hours preceding the surgical procedure.
• History of ipsilateral surgery during the previous 6 months.
• History of substance abuse.
• Pregnant woman or breastfeeding.
• Subjects deprived of their liberty or under guardianship (including temporary guardianship).
• Subjects no covered by social security scheme
• Experiencing any psychiatric condition or major cognitive impairment that may hamper completion of self-reported questionnaires.

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (4)

Centre Jean Perrin

Clermont-Ferrand, 63000, France

Location

Institut Curie

Paris, 75005, France

Location

Hopital Tenon

Paris, 75020, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (1)

• Albi-Feldzer A, Gayraud G, Dureau S, Auge M, Lemoine A, Raft J. Efficiency of interpectoral and pectoserratus plane blocks for breast surgery: A randomized controlled trial. J Clin Anesth. 2025 Apr;103:111805. doi: 10.1016/j.jclinane.2025.111805. Epub 2025 Mar 10.

  PMID: 40068583 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sodium Chloride; Ropivacaine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Pierre FUMOLEAU, PhD

  Institut Curie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 30, 2020
• Study Start: August 4, 2020
• Primary Completion: December 30, 2021
• Study Completion: January 28, 2022
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR (4)