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NCT Number: NCT04327063

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Centre Jean Perrin, Clermont-Ferrand, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Ongoing neoplasm or history of neoplasm other than breast cancer with the exception of: basal cell carcinoma, cervical carcinoma in situ, other treated cancer that has not relapsed during the 5 years preceding inclusion in the trial.
  • 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.

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

Treatment and study plan

Saline

Drug

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

Other names: NA Cl 0.9%

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

Other names: Naropeine

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

    Time frame: 3 hours

    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

Secondary outcomes

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

    Time frame: 48 hours

    VAS Scale (0 to 10 : 0 = no pain and 10 = Worst pain possible) at rest and after shoulder movement every 30 minutes during the first three postoperative hours in the PACU and the day surgery unit and then at home every 6 hours for the first 48 postoperative hours .

  2. Evaluation of acute pain until 48 postoperative hours

    Time frame: 48 hours

    Brief Pain Inventory Questionnaires at 48 hours will be collected with VAS Scale (0 to 10 : 0 = no pain and 10 = Worst pain possible)

  3. Evaluation of patient's satisfaction on pain management

    Time frame: 48 hours

    Scale of satisfaction ( 0 to 10 : 0 = very bad and 10 = excellent) of the pain management at 48 post-operative hours

  4. Evaluation of Remifentanil consumption during anesthesia

    Time frame: 3 hours

    Total dose of Remifentanil during anesthesia for a bispectral index between 40-60 or Analgesia Nociception Index (ANI) > 60%

  5. Evaluation of analgesic consumption during the first 48 postoperative hours

    Time frame: 48 hours

    Consumption of Ketoprofene in systematic, Paracetamol if VAS>3 and Tramadol if analgesia is not enough during 48 postoperative hours

  6. Evaluation of the incidence of nausea and vomiting during the first 48 postoperative hours

    Time frame: 48 hours

    Incidence of nausea and vomiting during the first 48 postoperative hours

  7. Evaluation of complications of Pecs during 48 postoperative hours

    Time frame: 48 hours

    Complications of Pecs block: pneumothorax, nerve injury, hypotension, vascular puncture and systemic toxicity of local anaesthetic (seizures, etc.) collected

  8. Evaluation of the incidence of serious adverse events during 30 days

    Time frame: 30 days

    Number of serious adverse events during 30 days after Pecs administration

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study title

A Double-blind Randomized Trial of Interpectoral Nerve Block (Pecs 1 and 2) With Ropivacaine Versus Placebo Before Breast Cancer Surgery: Effects on Acute Postoperative Pain. (MIRs 04)

Acronym: MIRs 04

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Mar 30, 2020
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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