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临床试验/NL-OMON56146
NL-OMON56146招募中不适用

Optimal postoperative chest tube and pain management in patients surgically treated for primary spontaneous pneumothorax; a randomized controlled trial. - Pneumotrial

Maxima Medisch Centrum0 个研究点目标入组 340 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
340

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
16 至 99(—)

入选标准

  • - Patients with primary spontaneous pneumothorax (PSP) and referred for surgery
  • due to recurrence, prolonged air leak (>=5 days), accompanied hemothorax or a
  • profession at risk (diving, polar explorers, working with compressed air). -
  • Age >= 16 years - Able to read and understand the Dutch language - Mentally able
  • to provide informed consent - Patients should have a preoperative chest CT scan
  • in order to exclude evident secondary pneumothorax. Previously made CT scans,
  • within a time range of maximum 5 years, are accepted.

排除标准

  • - Previous ipsilateral thoracic surgery (except diagnostic thoracoscopy only)
  • or ipsilateral thoracic radiotherapy
  • - Underlying lung disease that provoked the pneumothorax (secondary
  • pneumothorax): genetically proven Birt-Hogg-Dubé syndrome, periodic
  • pneumothorax in female patients in reproductive age with known endometriosis
  • (or known catamenial pneumothorax), pulmonary cystic fibrosis, lungfibrosis,
  • chronic obstructive pulmonary disease (COPD), active pneumonia, pulmonary
  • ipsilateral malignancy
  • - Contra-indications for thoracic epidural analgesia (TEA) (infection at skin
  • site, increased intracranial pressure, non-correctable coagulopathy, sepsis and
  • mechanical spine obstruction)
  • - Patients chronically using opioids will be excluded since postoperative
  • baseline opioid requirement will be higher and TEA remains the preferred
  • technique for these patients
  • - Allergic reactions to analgesics used in the study

研究者

发起方
Maxima Medisch Centrum

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