Status:
COMPLETED
MIRs 04 : Interpectoral Nerve Block With Ropivacaine Versus Placebo Before Breast Cancer Surgery
Lead Sponsor:
Institut Curie
Conditions:
Malignant Neoplasm of Breast
Eligibility:
FEMALE
18-85 years
Phase:
PHASE3
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.
Detailed 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 salin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2022
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT04327063
Start Date
August 4 2020
End Date
January 28 2022
Last Update
September 19 2025
Active Locations (4)
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1
Centre Jean Perrin
Clermont-Ferrand, France, 63000
2
Institut Curie
Paris, France, 75005
3
Hopital Tenon
Paris, France, 75020
4
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France, 54500