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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Saline (30 mL maximum) |
|
| Ropivacaïne | Experimental | Ropivacaïne 5 mg/mL (not to exceed 3 mg/kg and 30 ml of maximal volume) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline | Drug | Injection of the solution of Saline not exceeding 30 mL of maximal volume. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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| Name | Affiliation | Role |
|---|---|---|
| Pierre FUMOLEAU, PhD | Institut Curie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Jean Perrin | Clermont-Ferrand | 63000 | France | |||
| Institut Curie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40068583 | Result | 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. |
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Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Double
| Ropivacaine | Drug | 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 |
|
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Evaluation of the incidence of serious adverse events during 30 days | Number of serious adverse events during 30 days after Pecs administration | 30 days |
| Paris |
| 75005 |
| France |
| Hopital Tenon | Paris | 75020 | France |
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | 54500 | France |
| D017437 |
| Skin and Connective Tissue Diseases |
| D017670 |
| Sodium Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |