Clinical trial NCT04327063: MIRs 04 : Interpectoral Nerve Block With Ropivacaine Versus Placebo Before Breast Cancer Surgery
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malignant Neoplasm of Breast
Keywords: Surgery conservative
Nerve block
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 182
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 3 hours
Secondary outcomes:
measure: Evaluation of acute pain at rest and after shoulder movement until 48 postoperative hours
timeFrame: 48 hours
measure: Evaluation of acute pain until 48 postoperative hours
timeFrame: 48 hours
measure: Evaluation of patient's satisfaction on pain management
timeFrame: 48 hours
measure: Evaluation of Remifentanil consumption during anesthesia
timeFrame: 3 hours
measure: Evaluation of analgesic consumption during the first 48 postoperative hours
timeFrame: 48 hours
measure: Evaluation of the incidence of nausea and vomiting during the first 48 postoperative hours
timeFrame: 48 hours
measure: Evaluation of complications of Pecs during 48 postoperative hours
timeFrame: 48 hours
measure: Evaluation of the incidence of serious adverse events during 30 days
timeFrame: 30 days
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hopital Tenon
city: Vandoeuvre les Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Institut Curie
name: Pierre FUMOLEAU, PhD
role: STUDY_DIRECTOR
References: