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

Institut Curie

Status and phase: Completed; Phase 3

Conditions: Malignant Neoplasm of Breast

Treatments: Drug: Ropivacaine; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04327063

IC 2019-04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 182 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Age between 18 and 85 years.
3. ASA class 1, 2 or 3
4. Signed informed consent form.

Exclusion criteria

1. 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.
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 temporary guardianship).
11. Subjects no covered by social security scheme
12. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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182 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Saline (30 mL maximum)

Treatment:

Drug: Saline

Ropivacaïne

Experimental group

Description:

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

Treatment:

Drug: Ropivacaine