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

  • STATUS
    Recruiting
  • End date
    Dec 5, 2022
  • participants needed
    182
  • sponsor
    Institut Curie
Updated on 25 January 2021
carcinoma
carcinoma in situ
breast carcinoma
invasive breast cancer
sentinel node
breast-conserving surgery
mammogram

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.

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.

Details
Condition Breast Cancer, cancer, breast
Treatment ropivacaine, Saline
Clinical Study IdentifierNCT04327063
SponsorInstitut Curie
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 85 yrs?
Are you female?
Do you have Breast Cancer?
Do you have any of these conditions: Breast Cancer or cancer, breast?
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
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