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 - ER-One

INSTITUT CURIE0 个研究点目标入组 292 人开始时间: 2020年12月11日最近更新: 2023年8月28日

适应症

试验速览

暂无简介。

•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.
•There is no prohibition for people to take part simultaneously in another research and there is no exclusion cause at the end of the research period.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 192
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•1.Preoperative consumption of opioid in the patient's current médications 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, DIEP, 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 deprived of liberty or under legal protection.
•13.Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.

发起方