Breast SurgeryPhase 4ER-OneNCT04827030
ER-One: A Double-blind Trial of Erector Spinae Block (ESP) Versus Paravertebral Block (PVB) Before Breast Cancer Surgery
A Phase 4 study testing Ropivacaïne Hydrochloride by Erector Spinae block and Ropivacaïne Hydrochloride by Paravertebral block in people with Breast Surgery, run by Institut Curie at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Surgery
- What is being tested?
- Ropivacaïne Hydrochloride by Erector Spinae block and Ropivacaïne Hydrochloride by Paravertebral block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 5 sitesFrance
- Study dates
- 28 Jun 2021to 14 Jul 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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)…).
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre Jean Perrin
Clermont-Ferrand, 63000
AP-HP Hôpital Tenon
Paris, 75970
Institut Curie
Saint-Cloud, 92210
Institut Claudius Régaud UICT
Toulouse, 31059
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54500
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Surgery
- Being tested
- Ropivacaïne Hydrochloride by Erector Spinae block, Ropivacaïne Hydrochloride by Paravertebral block
- Keywords
- Breast, Surgery, anaesthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaïne Hydrochloride by Erector Spinae blockDrug
Also called Naropin
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 Paravertebral blockDrug
Also called Naropin
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Ropivacaïne Hydrochloride by Paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of ESP versus PVB on acute postoperative pain
Percentage of patients needed morphine during the first two postoperative hours in each treatment arm
Measured: 24 hours
Secondary outcomes (6)
Postoperative morphine consumption
Dose of opioid, in the Post-Anesthesia Care Unit (PACU)
Measured: 2 hours
Consumption of remifentanil in the Operating Room (OR)
Dose of Remifentanil during the Operating Room (OR) period
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start28 Jun 2021
- Primary completion14 Jun 2023
- Study completion14 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Double-blind Randomized non-inferiority Trial of erector spinae block (ESP) versus paravertebral block (PVB)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Pierre FUMOLEAU, PhD, Study director, Institut CurieJulien RAFT, MD, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827030
- Sponsor's protocol ID
- IC 2020-04
- Acronym
- ER-One
- Status last verified
- Sep 2025
- First submitted
- 23 Mar 2021
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Publications
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.
PubMed 40707285
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04827030
- Acronym / sponsor ID
- ER-One / IC 2020-04
- Conditions
- Breast Surgery
- Keywords
- Breast, Surgery, anaesthetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- 14 Jul 2023 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Double-blind Randomized non-inferiority Trial of erector spinae block (ESP) versus paravertebral block (PVB)
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine hydrochloride injected by Erector Spinae block | Active comparator | Drug: Ropivacaïne Hydrochloride by Erector Spinae blockThe injection will be performed with Ropivacaine hydrochloride 0.6 ml/kg of solution at 5 mg/ml up to 30 ml |
| Ropivacaine hydrochloride injected by Paravertebral block | Active comparator | Drug: Ropivacaïne Hydrochloride by Paravertebral blockThe injection will be performed with Ropivacaine hydrochloride 0.6 ml/kg of solution at 5 mg/ml up to 30 ml |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Woman with breast adenocarcinoma without metastasis or breast in situ adenocarcinoma (with or without breast reconstruction by prosthesis) to by treated:
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaïne Hydrochloride by Erector Spinae blockAlso: NaropinRopivacaïne 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. | Drug | Ropivacaine hydrochloride injected by Erector Spinae block |
| Ropivacaïne Hydrochloride by Paravertebral blockAlso: NaropinParavertebral 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. | Drug | Ropivacaine hydrochloride injected by Paravertebral block |
Primary outcome
Comparison of ESP versus PVB on acute postoperative pain
Time frame: 24 hours
Percentage of patients needed morphine during the first two postoperative hours in each treatment arm
6 secondary outcomes
Postoperative morphine consumption
Time frame: 2 hours
Consumption of remifentanil in the Operating Room (OR)
Time frame: During the period from the surgical incision to the end of the surgical dissection
Acute early postoperative pain by Visual Analog Scale (VAS)
Time frame: 24 hours
Percentage of nausea or vomiting
Time frame: 2 hours
Incidence of complications and side effects of each block
Time frame: 30 days
Post-operative extend of dermatomes blocked
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Results publication: PubMed 40707285Raft 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.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre FUMOLEAU, PhD study director
Institut Curie
Julien RAFT, MD principal investigator
Institut de Cancérologie de Lorraine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaïne Hydrochloride by Erector Spinae block and Ropivacaïne Hydrochloride by Paravertebral block in people with Breast Surgery, run by Institut Curie at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of ESP versus PVB on acute postoperative pain (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04827030, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.