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

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.

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.

Study Overview

• Status: Completed
• Conditions: Breast Surgery
• Intervention / Treatment: Drug: Ropivacaïne Hydrochloride by Erector Spinae block; Drug: Ropivacaïne Hydrochloride by Paravertebral block

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 292
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • Centre Jean Perrin
  • Paris, France, 75970
    • AP-HP Hopital Tenon
  • Saint-Cloud, France, 92210
    • Institut Curie
  • Toulouse, France, 31059
    • Institut Claudius Régaud UICT
  • Vandœuvre-lès-Nancy, France, 54500
    • Institut de Cancérologie de Lorraine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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
2. Patients aged between 18 and 85 years old.
3. ASA class 1, 2 or 3 (Physical Status Classification System of American Society of Anesthesiologists (ASA)).
4. Signed informed consent form.
5. Patient able to answer self-assessment questionnaires (sufficient understanding of evaluations and in French).
6. Patient affiliated to the health care insurance.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ropivacaine hydrochloride injected by Erector Spinae block; The injection will be performed with Ropivacaine hydrochloride 0.6 ml/kg of solution at 5 mg/ml up to 30 ml	Drug: Ropivacaïne Hydrochloride by Erector Spinae block; 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.; Other Names: Naropin
Active Comparator: Ropivacaine hydrochloride injected by Paravertebral block; The injection will be performed with Ropivacaine hydrochloride 0.6 ml/kg of solution at 5 mg/ml up to 30 ml	Drug: Ropivacaïne Hydrochloride by Paravertebral 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.; Other Names: Naropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Institut Curie
• Collaborators: National Cancer Institute, France
• Investigators: Principal Investigator: Julien RAFT, MD, Institut de Cancérologie de Lorraine; Study Director: Pierre FUMOLEAU, PhD, Institut Curie

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2021
• Primary Completion (Actual): June 14, 2023
• Study Completion (Actual): July 14, 2023

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Surgery; Breast; anaesthetics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: IC 2020-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• IPD Sharing Access Criteria: 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No