Status:
COMPLETED
ER-One: A Double-blind Trial of Erector Spinae Block (ESP) Versus Paravertebral Block (PVB) Before Breast Cancer Surgery
Lead Sponsor:
Institut Curie
Collaborating Sponsors:
National Cancer Institute, France
Conditions:
Breast Surgery
Eligibility:
FEMALE
18-85 years
Phase:
PHASE4
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 positio...
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 ultras...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2023
Estimated Enrollment :
292 Patients enrolled
Trial Details
Trial ID
NCT04827030
Start Date
June 28 2021
End Date
July 14 2023
Last Update
September 19 2025
Active Locations (5)
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1
Centre Jean Perrin
Clermont-Ferrand, France, 63000
2
AP-HP Hôpital Tenon
Paris, France, 75970
3
Institut Curie
Saint-Cloud, France, 92210
4
Institut Claudius Régaud UICT
Toulouse, France, 31059