Effect of erector spinae block versus para paravertebral block on acute postoperative pain before breast cancer surgery

Phase 1

• Conditions: ervous Block erector spinae plane (ESP) or paravertebral block (PVB) preoperatively in women with breast adenocarcinoma without metastasis or breast in situ adenocarcinoma to by treated either by breast-conserving surgery with axillary dissection, either by modified radical mastectomy with or without axillary or lymph node dissection.; MedDRA version: 20.1Level: LLTClassification code 10003034Term: Application site anesthesiaSystem Organ Class: 100000004867; MedDRA version: 20.0Level: HLTClassification code 10006290Term: Breast and nipple neoplasms malignantSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-004872-17-FR
• Lead Sponsor: INSTITUT CURIE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-11
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 292

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified