ER-One: A Double-blind Trial of Erector Spinae Block (ESP) Versus Paravertebral Block (PVB) Before Breast Cancer Surgery
NCT04827030 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 292
Last updated 2025-09-19
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
Interventions
- 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.
- 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.
Sponsors & Collaborators
-
National Cancer Institute, France
collaborator OTHER_GOV -
Institut Curie
lead OTHER
Principal Investigators
-
Pierre FUMOLEAU, PhD · Institut Curie
-
Julien RAFT, MD · Institut de Cancérologie de Lorraine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-28
- Primary Completion
- 2023-06-14
- Completion
- 2023-07-14
Countries
- France
Study Locations
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