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临床试验/EUCTR2020-003300-14-DK
EUCTR2020-003300-14-DK进行中(未招募)1 期

Botulinum Toxin A as Treatment for Chronic Postsurgical Pain Following LungCancer Surgery: a Randomized Controlled Pilot Trial

Department of Cardiothoracic Surgery, Aalborg Universityhospital0 个研究点目标入组 30 人开始时间: 2020年8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
30

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
All

入选标准

  • 1. Patients of 18 years of age or above.
  • 2. Patients who have undergone pulmonary surgery because of suspicion
  • or confirmed pulmonary malignancies.
  • 3. Patients who are radically treated for pulmonary malignancy
  • 4. Patients who suffers from chronic pain or unpleasant sensations at the site of scar at least six months after surgery with fully healed surgical wounds.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range 10
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • 1. Patients who cannot understand oral and written information.
  • 2. Patients who were not radically operated.
  • 3. Patients with other concomitant or other active cancer diseases.
  • 4. Patients with chronic pain in the chest wall prior to surgery.
  • 5. Pregnant women or women planning to get pregnant in the study period.
  • 6. Patients with autoimmune neuromuscular diseases, sclerosis, peripheral
  • neuromuscular disturbances and general muscle weakness or atrophy.
  • 7. Patients with intolerance or allergy to BOTOX®.
  • 8. Patients who are at present treated with Onabotulinum toxin A or similar neuromuscular blocking drug or have received such in the past year.

研究者

发起方
Department of Cardiothoracic Surgery, Aalborg Universityhospital

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