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临床试验/EUCTR2018-001191-38-FI
EUCTR2018-001191-38-FI进行中(未招募)1 期

evobupivacaine versus Liposomal Bupivacaine (Exparel®) for Treatment of Pain and Disability in Lateral Epicondylitis – Off-Label, Investigator Initiated Randomized, Controlled, Double-Blind Cross-Over Treatment Trial

Turku University Hospital0 个研究点目标入组 50 人开始时间: 2020年1月7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)
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

  • -age 18-65
  • -chronic lateral epicondylitis (duration >3 months)
  • -pain in lateral epicondyle
  • -pain in resisted wrist extension in elbow extension (Cozen test)
  • -X-ray or Magnetic resonance imaging (MRI) of the elbow (<12 months from enrollment) with no pathological findings other than lateral epicondylitis
  • 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 50
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • -pregnancy
  • -unemployment
  • -allergy to levobupivacaine, bupivacaine or liposomal bupivacaine
  • -constant use of strong analgesics (e.g. opioids)
  • -other source of elbow pain (e.g. medial epicondylitis, distal biceps/triceps tendinitis)
  • -bilateral epicondylitis
  • -inability to give informed consent
  • -inability to understand the enrollment forms or to fill patient diary (forms are written in Finnish)
  • -previous injection treatment (e.g. cortisone, botulin toxin A, autologous plasma) for lateral epicondylitis during the past 3 months
  • -severe hepatic disease, or other underlying severe illness (cardiac failure, cancer, other systemic diseases)

研究者

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