Clinical trial · Interventional
MIRs 04 : Interpectoral Nerve Block With Ropivacaine Versus Placebo Before Breast Cancer Surgery
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)
NCT04327063CI-TRIAL-00095480MIRs 04completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm of Breast | Malignant Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ropivacaine | Drug | — | UNRESOLVED |
| Saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Saline (30 mL maximum)
- interventionNames
- Drug: Saline
- type
- EXPERIMENTAL
- label
- Ropivacaïne
- description
- Ropivacaïne 5 mg/mL (not to exceed 3 mg/kg and 30 ml of maximal volume)
- interventionNames
- Drug: Ropivacaine
Primary outcomes (1)
- measure
- 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
- timeFrame
- 3 hours
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTAlbi-Feldzer A, Gayraud G, Dureau S, Auge M, Lemoine A, Raft J. Efficiency of interpectoral and pectoserratus plane blocks for breast surgery: A randomized controlled trial. J Clin Anesth. 2025 Apr;103:111805. doi: 10.1016/j.jclinane.2025.111805. Epub 2025 Mar 10. PMID 40068583