Malignant Neoplasm of BreastPhase 3MIRs 04NCT04327063
MIRs 04 : Interpectoral Nerve Block With Ropivacaine Versus Placebo Before Breast Cancer Surgery
A Phase 3 study testing Saline and Ropivacaine in people with Malignant Neoplasm of Breast, run by Institut Curie at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Malignant Neoplasm of Breast
- What is being tested?
- Saline and Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 4 sitesFrance
- Study dates
- 4 Aug 2020to 28 Jan 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre Jean Perrin
Clermont-Ferrand, 63000
Institut Curie
Paris, 75005
Hopital Tenon
Paris, 75020
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54500
About this study
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)
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.
Read the 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.
- Conditions
- Malignant Neoplasm of Breast
- Being tested
- Saline, Ropivacaine
- Keywords
- Surgery conservative, Nerve block
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
Also called NA Cl 0.9%
Injection of the solution of Saline not exceeding 30 mL of maximal volume.
RopivacaineDrug
Also called Naropeine
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
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Saline (30 mL maximum) Receives: Drug: Saline |
| Ropivacaïne | Experimental | Ropivacaïne 5 mg/mL (not to exceed 3 mg/kg and 30 ml of maximal volume) Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 hours
Secondary outcomes (8)
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 .
Measured: 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)
Measured: 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
Measured: 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%
Measured: 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
Measured: 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
Measured: 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
Measured: 48 hours
Evaluation of the incidence of serious adverse events during 30 days
Number of serious adverse events during 30 days after Pecs administration
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start4 Aug 2020
- Primary completion30 Dec 2021
- Study completion28 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Neoplasm of BreastStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre FUMOLEAU, PhD, Study director, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327063
- Sponsor's protocol ID
- IC 2019-04
- Acronym
- MIRs 04
- Status last verified
- Sep 2025
- First submitted
- 9 Mar 2020
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Publications
Albi-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.
PubMed 40068583
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04327063
- Acronym / sponsor ID
- MIRs 04 / IC 2019-04
- Conditions
- Malignant Neoplasm of Breast
- Keywords
- Surgery conservative, Nerve block
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: SalineSaline (30 mL maximum) |
| Ropivacaïne | Experimental | Drug: RopivacaineRopivacaïne 5 mg/mL (not to exceed 3 mg/kg and 30 ml of maximal volume) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SalineAlso: NA Cl 0.9%Injection of the solution of Saline not exceeding 30 mL of maximal volume. | Drug | Placebo |
| RopivacaineAlso: NaropeineDilution 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 | Drug | Ropivacaïne |
Primary outcome
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
Time frame: 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
8 secondary outcomes
Evaluation of acute pain at rest and after shoulder movement until 48 postoperative hours
Time frame: 48 hours
Evaluation of acute pain until 48 postoperative hours
Time frame: 48 hours
Evaluation of patient's satisfaction on pain management
Time frame: 48 hours
Evaluation of Remifentanil consumption during anesthesia
Time frame: 3 hours
Evaluation of analgesic consumption during the first 48 postoperative hours
Time frame: 48 hours
Evaluation of the incidence of nausea and vomiting during the first 48 postoperative hours
Time frame: 48 hours
Evaluation of complications of Pecs during 48 postoperative hours
Time frame: 48 hours
Evaluation of the incidence of serious adverse events during 30 days
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Results publication: PubMed 40068583Albi-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.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre FUMOLEAU, PhD study director
Institut Curie
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Saline and Ropivacaine in people with Malignant Neoplasm of Breast, run by Institut Curie at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04327063, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.