Efficacy of Pectoral Nerve (PECS II) Block for Breast Conserving Surgery: A Prospective Randomized Controlled Trial

Phase 4

Completed

• Conditions: breastcancer; mammacarcinoma; 10006291

• Registration Number: NL-OMON50121
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

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 .

Exclusion Criteria

- Women above 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess whether postoperative NRS pain scores in the breast after BCS is<br /><br>lower in women who receive a preoperative PECS II block than in women who<br /><br>receive a sham block. </p><br>