Efficacy of Pectoral Nerve (PECS II) Block with Liposomal Bupivacaine versus Levobupivacaine for Patients undergoing a Mastectomy: A Prospective Randomized Controlled Trial.

Phase 3

Recruiting

Conditions: Breast cancer
mammacarcinoma
10006291

Registration Number: NL-OMON53831

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 130

Inclusion Criteria

- Unilateral mastectomy
- Written informed consent
- Asa I-III

Exclusion Criteria

- Age <18 jaar
- (Oncoplastic) breast conserving surgery
- Bilateral surgery
- Bleeding disorder or coagulopathy
- Chest wall deformity or infection of injection site
- Another (additional) nerve block (TPVB or epidural anesthesia)
- Autologous or implant based breast reconstruction
- Known allergy for levobupivacaine or local anesthetics from the amide group
- Known allergy or contra-indication for NSAIDs
- Chronic use of opiates preoperatively (>12 weeks)
- Previous breast surgery ipsi- or contralateral less than 5 years prior to
planned mastectomy (except diagnostic biospies)
- Not able to speak or understand the Dutch language fluently
- Pregnancy or breast feeding
- Psychological, neurological, familial, sociological or geographical factors
that could potentially hamper compliance with the study protocol

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Postoperative (first 72 hours) NRS pain scores</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Postoperative painscores in the axilla<br /><br>- Intraoperative need of opiates<br /><br>- Postoperatieve need of opiates and other painkillers<br /><br>- Chronic pain (>12 weeks)<br /><br>- Satisfaction, measured by BREAST-Q mastectomy<br /><br>- Time to discharge<br /><br>- Postoperative nausea and vomiting (PONV) </p><br>