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

NCT04827030 | Completed Phase 4

• 1 other identifier: IC 2020-04
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Breast Surgery

Keywords

Breast; Surgery; anaesthetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Postoperative morphine consumption

  2 hours

• Consumption of remifentanil in the Operating Room (OR)

  During the period from the surgical incision to the end of the surgical dissection

• Acute early postoperative pain by Visual Analog Scale (VAS)

  24 hours

• Percentage of nausea or vomiting

  2 hours

• Incidence of complications and side effects of each block

  30 days

Study Arms (2)

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

Drug: Ropivacaïne Hydrochloride by Erector Spinae block

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

Drug: Ropivacaïne Hydrochloride by Paravertebral block

Interventions

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.

Also known as: Naropin

Ropivacaine hydrochloride injected by Erector Spinae block

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.

Also known as: Naropin

Ropivacaine hydrochloride injected by Paravertebral block

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Allergy to local anaesthetics and morphine and NSAID.
• Local skin inflammation at the puncture area.
• 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.

Sponsors & Collaborators

• Institut Curie: lead
• National Cancer Institute, France: collaborator

Study Sites (5)

Centre Jean Perrin

Clermont-Ferrand, 63000, France

Location

AP-HP Hôpital Tenon

Paris, 75970, France

Location

Institut Curie

Saint-Cloud, 92210, France

Location

Institut Claudius Régaud UICT

Toulouse, 31059, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (1)

• 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.

  PMID: 40707285 RESULT

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Pierre FUMOLEAU, PhD

  Institut Curie

  STUDY DIRECTOR

• Julien RAFT, MD

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 1, 2021
• Study Start: June 28, 2021
• Primary Completion: June 14, 2023
• Study Completion: July 14, 2023
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• 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).

Locations

FR (5)