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

  • STATUS
    Recruiting
  • End date
    Aug 1, 2023
  • participants needed
    292
  • sponsor
    Institut Curie
Updated on 25 November 2021

Summary

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.

Description

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.

Details
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

Eligibility

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note