Efficacy of PECSII block of the breast for breast conserving surgery

Phase 1

• Conditions: Breast cancerPECSII blockBreast conserving surgeryLumpectomy; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-004039-21-NL
• Lead Sponsor: St Antonius Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-21
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

- Female gender.
- Unilateral breast conserving surgery.
- Written informed consent according to ICH/GCP and national regulations.
- ASA (American Society of Anesthesiologists) Class I-III .

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 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130

Exclusion Criteria

- Women < 18 year old.
- Bilateral surgery.
- Bleeding disorder or coagulopathy.
- Chest wall deformity or infection of injection site.
- Another (additional) nerve block (such as TPVB or epidural anesthesia).
- Oncoplastic breast conserving surgery.
- Autologous or implant based breast reconstruction.
- Known allergy for levobupivacaine or local anesthetics from the amide group.
- Chronic use of analgesics / opiates preoperatively (> 12 weeks).
- Previous breast surgery ipsi- or contralateral (except diagnostic biopsies).
- Not able to speak or understand the Dutch language fluently.
- Palliative surgery.
- Metastatic disease.
- Pregnancy or breast feeding.
- Psychological, neurological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol.
- Other concurrent solid tumor.

Study & Design

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