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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-04

Study Completion Date

2022-01-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Malignant Neoplasm of Breast

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double

Study Groups

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Placebo

Saline (30 mL maximum)

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

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

Ropivacaïne

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

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type 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

Interventions

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Saline

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

Intervention Type DRUG

Ropivacaine

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

Intervention Type DRUG

Other Intervention Names

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NA Cl 0.9% Naropeine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No