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临床试验/EUCTR2021-004417-40-NO
EUCTR2021-004417-40-NO进行中(未招募)1 期

The effect of pregabalin in the treatment of acute post-operative peripheral neuropathic pain – a pilot study

Helse Bergen HF0 个研究点目标入组 50 人开始时间: 2021年11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)
入组人数
50

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

入选标准

  • Participant must be 18 years of age inclusive, at the time of signing the informed consent.
  • Type of Participant and Disease Characteristics:
  • Patients that have verified NeP following surgery and are identified and included within 7 days after nerve injury
  • Informed Consent:
  • Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • 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 40
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 10

排除标准

  • Participants are excluded from the study if any of the following criteria apply:
  • Medical Conditions:
  • 1.Psychiatric disease
  • 2.Renal failure (GFR <60)
  • 3.Patients that are cognitively impaired
  • 4.Daily substance abuse (drugs/alchohol)
  • 5.Pregnancy
  • Prior/Concomitant Therapy:
  • 1.Patients that use current 1st line NeP-medication at admission, regardless of indication. This includes Lyrica, gabapentin, SNRI and Tricyclic antidepressiva.

研究者

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