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

Phase 4

Completed

Conditions: <p>Breast cancer</p>
10006232

Registration Number: NL-OMON28887

Lead Sponsor: St. Antonius Hospital

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following 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

A potential subject who meets any of the following criteria will be excluded from participation in this study: - 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>NRS pain scores in the breast after breast conserving surgery</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Postoperative NRS pain scores in the axilla. - Intraoperative need of opiates (milligrams). - Postoperative need of opiates or other pain killers (milligrams). - Patient-reported chronic (> 12 weeks) pain (yes/no). - Patient satisfaction, measured by the BREAST-Q BCT. - Postoperative time that women need to be observed in the recovery room (minutes). - Time until women are discharged from the hospital (hours). - Use of additional anti-emetics for PONV (yes/no). - Vomiting (yes/no). - Operating time (minutes). - Complications (wound infection rate, hematoma, abscess, pneumothorax).</p><br>