CTIS2024-515183-30-00进行中（未招募）1 期
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 - NL83450.100.23
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
入选标准
- •Unilateral mastectomy., Written informed consent according to ICH/GCP and national regulations., ASA (American Society of Anesthesiologists) Class I-III.
排除标准
- •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).
研究者
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