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

Study Overview
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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.

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.

Official Title
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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)

Conditions
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Malignant Neoplasm of Breast

Intervention / Treatment
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* Drug: Saline
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Saline (30 mL maximum) | Drug: Saline<br>* Injection of the solution of Saline not exceeding 30 mL of maximal volume.<br>* Other names: NA Cl 0.9%;|
| Experimental: Ropivacaïne<br>Ropivacaïne 5 mg/mL (not to exceed 3 mg/kg and 30 ml of maximal volume) | Drug: Ropivacaine<br>* 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<br>* Other names: Naropeine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Percentage of patients treated with step 2 or 3 analgesics during the first three postoperative hours after tumorectomy plus sentinel lymph node dissection, between the group with Ropivacaïne and the group with placebo | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of acute pain at rest and after shoulder movement until 48 postoperative hours | VAS Scale (0 to 10 : 0 = no pain and 10 = Worst pain possible) at rest and after shoulder movement every 30 minutes during the first three postoperative hours in the PACU and the day surgery unit and then at home every 6 hours for the first 48 postoperative hours . | 48 hours | 
| Evaluation of acute pain until 48 postoperative hours | Brief Pain Inventory Questionnaires at 48 hours will be collected with VAS Scale (0 to 10 : 0 = no pain and 10 = Worst pain possible) | 48 hours | 
| Evaluation of patient's satisfaction on pain management | Scale of satisfaction ( 0 to 10 : 0 = very bad and 10 = excellent) of the pain management at 48 post-operative hours | 48 hours | 
| Evaluation of Remifentanil consumption during anesthesia | Total dose of Remifentanil during anesthesia for a bispectral index between 40-60 or Analgesia Nociception Index (ANI) > 60% | 3 hours | 
| Evaluation of analgesic consumption during the first 48 postoperative hours | Consumption of Ketoprofene in systematic, Paracetamol if VAS>3 and Tramadol if analgesia is not enough during 48 postoperative hours | 48 hours | 
| Evaluation of the incidence of nausea and vomiting during the first 48 postoperative hours | Incidence of nausea and vomiting during the first 48 postoperative hours | 48 hours | 
| Evaluation of complications of Pecs during 48 postoperative hours | Complications of Pecs block: pneumothorax, nerve injury, hypotension, vascular puncture and systemic toxicity of local anaesthetic (seizures, etc.) collected | 48 hours | 
| Evaluation of the incidence of serious adverse events during 30 days | Number of serious adverse events during 30 days after Pecs administration | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery conservative, Nerve block