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临床试验/NL-OMON50121
NL-OMON50121已完成4 期

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

Sint Antonius Ziekenhuis0 个研究点目标入组 200 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
已完成
入组人数
200

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 99(—)

入选标准

  • - Female gender.
  • - Unilateral breast conserving surgery.
  • - Written informed consent according to ICH/GCP and national regulations.
  • - ASA (American Society of Anesthesiologists) Class I-III .

排除标准

  • - 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.

研究者

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