MIRs 04 : Interpectoral Nerve Block With Ropivacaine Versus Placebo Before Breast Cancer Surgery (NCT04327063) | Clinical Trial Compass
CompletedPhase 3
MIRs 04 : Interpectoral Nerve Block With Ropivacaine Versus Placebo Before Breast Cancer Surgery
France182 participantsStarted 2020-08-04
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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