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

  • End date
    Aug 1, 2023
  • participants needed
  • sponsor
    Institut Curie
Updated on 25 November 2021


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.

Condition Breast Surgery
Treatment Ropivacaïne Hydrochloride by Erector Spinae block, Ropivacaïne Hydrochloride by Paravertebral block
Clinical Study IdentifierNCT04827030
SponsorInstitut Curie
Last Modified on25 November 2021


Yes No Not Sure

Inclusion Criteria

Woman with breast adenocarcinoma without metastasis or breast in situ adenocarcinoma (with or without breast reconstruction by prosthesis) to by treated
either by breast-conserving surgery with axillary dissection
either by modified radical mastectomy with axillary dissection
either by modified radical mastectomy with lymph node dissection
either by modified radical mastectomy without axillary
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

Preoperative consumption of opioid in the patient's current medications within three months before inclusion
Ipsilateral breast surgery during 3 months prior to the inclusion
Allergy to local anaesthetics and morphine and NSAID
Local skin inflammation at the puncture area
Bilateral breast surgery planned at inclusion
Major immediate ipsilateral breast reconstruction by using tissue flap procedure (example: latissimus dorsi flap, Deep Inferior Epigastric Perforator (DIEP), Transverse Rectus Abdominis Musculocutaneous (TRAM))
Any contra-indication or patient's refusal for regional anesthesia
Male subjects
Pregnant woman or breastfeeding
B blocker medication
Patient already participating in an analgesia protocol that may interfere with the pain assessment criteria
Patient under legal protection
Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons
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