跳至主要内容
临床试验/EUCTR2013-001873-25-SE
EUCTR2013-001873-25-SE进行中(未招募)1 期

Will intrathecal analgesia contribute to a faster recovery compared with epidural analgesia after open surgery for gynecological cancer. An open controlled randomized study. - Speed

County Council of Östergötland0 个研究点目标入组 60 人开始时间: 2013年5月29日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
60

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

  • Women 18 – 70 years.
  • Women with gynecological cancer (suspected or verified) planned for explorative laparatomy through a middle-line with a curative purpose.
  • WHO performance status < 2.
  • ASA 1-2.
  • Women that understand and can express themselves in Swedish.
  • Women that after verbal and written information accept participation in the study and have signed an informed consent.
  • 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 60
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 60

排除标准

  • Women where surgery is expected to include part/s, other than the abdominal surgery, where intrathecal or epidural analgesia is not expected to be effective
  • Women with contra indications for intrathecal or epidural anesthesia.
  • Women who are physically disabled and therefore nor expected to be mobilized on the day after surgery in the same way as non-disabled.
  • Women with a mental retardation that makes it impossible to fill in the relevant questionnaires or makes it impossible to understand the meaning of participation, or if it is ethically doubtful to include the women.
  • Women with severe psychiatric or mental disorder and any condition, which would exclude the women from conducting regional anesthesia in the standardized manner of the study.

研究者

发起方
County Council of Östergötland

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