APECS II: Comparing the efficacy of Pectoral Nerve (PECS II) Block with long-acting liposomal bupivacaine versus levobupivacaine for Mastectomy Surgery: A Multicenter Prospective Randomized Controlled Trial
- Conditions
- Postoperative and chronic pain after breast cancer surgeryTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-515183-30-00
- Lead Sponsor
- St. Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 130
Unilateral mastectomy., Written informed consent according to ICH/GCP and national regulations., ASA (American Society of Anesthesiologists) Class I-III.
Patients < 18 year old., 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, Bilateral surgery., Bleeding disorder or coagulopathy., Chest wall deformity or infection of injection site., Another (additional) nerve block (such as TPVB or epidural anesthesia)., Autologous or implant based breast reconstruction., Known allergy for (levo)bupivacaine or local anesthetics from the amide group., Known allergy or contra-indication for NSAID., Chronic use of opiates preoperatively (> 12 weeks).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method