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| Name | Class |
|---|---|
| National Cancer Institute, France | OTHER_GOV |
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The block (ESP or PVB) will be performed preoperatively in the recovery room under standard monitoring. After setting a peripheral venous access, patient will be installed on lateral decubitus position on the opposite side of the block.
The block will be performed with IV Remifentanil sedation Target-Controlled Infusion mode at 2ng/ml and oxygen therapy.
For the erector spinae plane block:
The puncture will be performed with ultrasound guidance. The ultrasound probe will be placed parallel to the spine parasagittally at the T3 transverse process level. The needle will be introduced and visualized to the plane of the ultrasound image ("in plane").
The desired injection site is between the fascia of the erector muscle of the spine and the transverse process at the T3 level. The operator ensures the correct localization of the needle with saline solution. Then 0.50% Ropivacaine hydrochloride will be injected at a dose of 0.6 ml/kg of actual weight, without exceeding 30 ml.
For paravertebral block:
The T2 intervertebral space will be located by identifying compared to C7, a prominent cervical vertebra, or by ultrasound by counting the thoracic vertebrae from the first rib. The paravertebral space will be identified by placing the ultrasound probe in a parasagittal or transverse position. The needle will go through the paravertebral muscles and the costo-transverse ligament or by a latero-medial approach using ultrasound. The block will be performed using a 22-gauge 8cm long needle. When the paravertebral space has been reach, an aspiration test will be performed and then 0.6 ml/kg of solution (Ropivacaine hydrochloride solution at 5 mg/ml up to 30 ml) will be injected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine hydrochloride injected by Erector Spinae block | Active Comparator | The injection will be performed with Ropivacaine hydrochloride 0.6 ml/kg of solution at 5 mg/ml up to 30 ml |
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| Ropivacaine hydrochloride injected by Paravertebral block | Active Comparator | The injection will be performed with Ropivacaine hydrochloride 0.6 ml/kg of solution at 5 mg/ml up to 30 ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaïne Hydrochloride by Erector Spinae block | Drug | Ropivacaïne Hydrochloride Erector Spinae puncture will be performed with ultrasound guidance. Then 0.50% Ropivacaine hydrochloride will be injected at a dose of 0.6 ml/kg of actual weight, without exceeding 30 ml. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of ESP versus PVB on acute postoperative pain | Percentage of patients needed morphine during the first two postoperative hours in each treatment arm | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative morphine consumption | Dose of opioid, in the Post-Anesthesia Care Unit (PACU) | 2 hours |
| Consumption of remifentanil in the Operating Room (OR) | Dose of Remifentanil during the Operating Room (OR) period |
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Inclusion Criteria:
Woman with breast adenocarcinoma without metastasis or breast in situ adenocarcinoma (with or without breast reconstruction by prosthesis) to by treated:
Patients aged between 18 and 85 years old.
ASA class 1, 2 or 3 (Physical Status Classification System of American Society of Anesthesiologists (ASA)).
Signed informed consent form.
Patient able to answer self-assessment questionnaires (sufficient understanding of evaluations and in French).
Patient affiliated to the health care insurance.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre FUMOLEAU, PhD | Institut Curie | Study Director |
| Julien RAFT, MD | Institut de Cancérologie de Lorraine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Jean Perrin | Clermont-Ferrand | 63000 | France | |||
| AP-HP Hôpital Tenon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40707285 | Result | Raft J, Dureau S, Fuzier R, Auge M, Lamotte AS, Lemoine A, Albi-Feldzer A. Erector spinae plane block versus paravertebral block for major oncological breast surgery: a multicentre randomised controlled trial. Br J Anaesth. 2025 Sep;135(3):772-778. doi: 10.1016/j.bja.2025.05.051. Epub 2025 Jul 24. |
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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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A Double-blind Randomized non-inferiority Trial of erector spinae block (ESP) versus paravertebral block (PVB)
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| Ropivacaïne Hydrochloride by Paravertebral block | Drug | Paravertebral puncture will be performed with ultrasound guidance. Then 0.50% Ropivacaine hydrochloride will be injected at a dose of 0.6 ml/kg of actual weight, without exceeding 30 ml. |
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| During the period from the surgical incision to the end of the surgical dissection |
| Acute early postoperative pain by Visual Analog Scale (VAS) | VAS (no pain=0, worst pain=10) at arrival in the PACU, every 30 minutes in the Post-Anaesthesia Care Unit (PACU), VAS at 4 and 24 hours. Pain scores will be evaluated at rest and after shoulder movement | 24 hours |
| Percentage of nausea or vomiting | Number of patient who related nausea or vomiting side effects will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0) | 2 hours |
| Incidence of complications and side effects of each block | Complications and side effects of each block will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE 5.0) | 30 days |
| Post-operative extend of dermatomes blocked | The extent of dermatomes blocked as measured by clinical examination to determine area where temperature perception change | 2 hours |
| Paris |
| 75970 |
| France |
| Institut Curie | Saint-Cloud | 92210 | France |
| Institut Claudius Régaud UICT | Toulouse | 31059 | France |
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | 54500 | France |
| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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