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

Malignant Neoplasm of Breast Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04327063
• Other study ID #: IC 2019-04
• Status: Completed
• Phase: Phase 3
• Start date: August 4, 2020
• Est. completion date: January 28, 2022

Study information

• Verified date: January 2024
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: January 28, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Malignant Neoplasm of Breast
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Centre Jean Perrin	Clermont-Ferrand
France	Hopital Tenon	Paris
France	Institut Curie	Paris
France	Institut de Cancérologie de Lorraine	Vandoeuvre les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Evaluation of the incidence of serious adverse events during 30 days	Number of serious adverse events during 30 days after Pecs administration	30 days