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

Phase 3

Completed

• Conditions: Malignant Neoplasm of Breast
• Interventions: Drug: Saline; Drug: Ropivacaine

• Registration Number: NCT04327063
• Lead Sponsor: Institut Curie

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.

Study Timeline

• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-27
• Study First Posted: 2020-03-30
• Study Start: 2020-08-04
• Primary Completion: 2021-12-30
• Study Completion: 2022-01-28
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-26
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 182

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline	Saline (30 mL maximum)
Ropivacaïne	Ropivacaine	Ropivacaïne 5 mg/mL (not to exceed 3 mg/kg and 30 ml of maximal volume)

Primary Outcome Measures

Name	Time	Method
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	3 hours	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

Secondary Outcome Measures

Name	Time	Method
Evaluation of acute pain at rest and after shoulder movement until 48 postoperative hours	48 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 .
Evaluation of acute pain until 48 postoperative hours	48 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)
Evaluation of patient's satisfaction on pain management	48 hours	Scale of satisfaction ( 0 to 10 : 0 = very bad and 10 = excellent) of the pain management at 48 post-operative hours
Evaluation of Remifentanil consumption during anesthesia	3 hours	Total dose of Remifentanil during anesthesia for a bispectral index between 40-60 or Analgesia Nociception Index (ANI) \> 60%
Evaluation of analgesic consumption during the first 48 postoperative hours	48 hours	Consumption of Ketoprofene in systematic, Paracetamol if VAS\>3 and Tramadol if analgesia is not enough during 48 postoperative hours
Evaluation of the incidence of nausea and vomiting during the first 48 postoperative hours	48 hours	Incidence of nausea and vomiting during the first 48 postoperative hours
Evaluation of complications of Pecs during 48 postoperative hours	48 hours	Complications of Pecs block: pneumothorax, nerve injury, hypotension, vascular puncture and systemic toxicity of local anaesthetic (seizures, etc.) collected
Evaluation of the incidence of serious adverse events during 30 days	30 days	Number of serious adverse events during 30 days after Pecs administration

Trial Locations

Locations (4)

Institut Curie; 🇫🇷 Paris, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Hopital Tenon; 🇫🇷 Paris, France

Institut de Cancérologie de Lorraine; 🇫🇷 Vandoeuvre les Nancy, France