跳至主要内容
临床试验/EUCTR2019-001016-35-DK
EUCTR2019-001016-35-DK进行中(未招募)1 期

The ultrasound-guided multiple-injection costotransverse block for mastectomy and primary reconstructive surgery. A double blind, randomised, placebo controlled trial.

Associate Professor, Consultant Jens Børglum0 个研究点目标入组 36 人开始时间: 2019年3月14日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
36

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • Scheduled for elective unilateral mastectomy and primary reconstructive surgery (UMPR) with subpectoral implant due to breast cancer
  • Age above/equal to 18 years at the date of inclusion
  • Have received thorough information, orally and in written, and signed the Informed Consent” form on participation in the study.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 30
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 6

排除标准

  • Scheduled for elective UMPR surgery due to breast cancer combined with simultaneous contralateral major breast surgery (mastectomy, mastopexy and subpectoral breast reconstruction). Minor contralateral surgery (e.g. lipofilling) are accepted.
  • Scheduled free flap reconstructive surgery
  • Inability to cooperate
  • Inability to speak, read and understand Danish
  • Allergy to local anaesthetics or opioids
  • Daily intake of opioids, according to the investigators decision
  • Illegal drug and/or substance abuse, according to the investigators decision
  • Local infection at the site of injection or systemic infection
  • Difficult sonoanatomical visualisation of the target area necessary for the block execution
  • Substantial co-morbidity, ASA>3
  • Severe hypovolemia
  • Pregnant or breastfeeding

研究者

发起方
Associate Professor, Consultant Jens Børglum

相似试验