Symptoms and General Pathology

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Rare Diseases

Pain, Postoperative

Breast Neoplasms

Pain

Acute Graft Versus Host Disease

Central Nervous System Depressants

All Drugs and Chemicals

Pharmaceutical Solutions

Anesthetics

Ropivacaine

Anesthetics, Local

The injection will be performed with Ropivacaine hydrochloride 0.6 ml/kg of solution at 5 mg/ml up to 30 ml

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.

Ropivacaïne Hydrochloride by Erector Spinae block

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.

Ropivacaïne Hydrochloride by Paravertebral block

Pierre FUMOLEAU, PhD

Julien RAFT, MD

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.

A Double-blind Randomized non-inferiority Trial of erector spinae block (ESP) versus paravertebral block (PVB)

ER-One: A Double-blind Trial of Erector Spinae Block (ESP) Versus Paravertebral Block (PVB) Before Breast Cancer Surgery

A Double-blind Randomized Non-inferiority Trial of Erector Spinae Block (ESP) Versus Paravertebral Block (PVB) Before Breast Cancer Surgery: Effects on Acute Postoperative Pain.

Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Percentage of patients needed morphine during the first two postoperative hours in each treatment arm

Dose of opioid, in the Post-Anesthesia Care Unit (PACU)

Dose of Remifentanil during the Operating Room (OR) period

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

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)

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)

The extent of dermatomes blocked as measured by clinical examination to determine area where temperature perception change

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
ER-One: A Double-blind Trial of Erector Spinae Block (ESP) Versus Paravertebral Block (PVB) Before Breast Cancer Surgery	NCT04827030	Breast Surgery	Ropivacaïne Hyd... Ropivacaïne Hyd...	18 Years - 85 Years	Institut Curie
ER-One: A Double-blind Trial of Erector Spinae Block (ESP) Versus Paravertebral Block (PVB) Before Breast Cancer Surgery	NCT04827030	Breast Surgery	Ropivacaïne Hyd... Ropivacaïne Hyd...	18 Years - 85 Years	Institut Curie

Spots Global Cancer Trial Database for ropivacaïne hydrochloride by erector spinae block