跳至主要内容
临床试验/EUCTR2015-001769-14-ES
EUCTR2015-001769-14-ES进行中(未招募)1 期

Analgesic efficacy of intravenous lacosamide administered perioperatively for thoracic surgery with thoracotomy approach. - LACO15

Javier E. Morales Sarabia0 个研究点开始时间: 2016年9月26日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方

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

  • - Patients over 18 years and less than or equal to 75 years.
  • - Patients undergoing thoracic surgery for non-small cell lung cancer (NSCLC) with curative intent or resection of lung metastases by thoracotomy.
  • - Patients ASA I-III.
  • - Signature of 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 10

排除标准

  • - Patient refusal.
  • - Other diseases that warrant its non-inclusion according to medical criteria: severe renal disease (stage 3 and 4), liver disease (stages B and C ChildPugh) or psychiatric, heart rhythm disorders, bleeding disorders, pregnancy and lactation.
  • - Lacosamide allergy, NSAIDs, local anesthetics and / or morphic.
  • - Alcoholism.
  • - Drug addiction.
  • - Concurrent use of opioid analgesics or anti-epileptic type in the immediate preoperative period.
  • - History of epilepsy or any neurological condition that needs treatment with lacosamide or other antiepileptic drug.
  • - Functional status ASA> III.
  • - Inability to understand the pain assessment scales.
  • - Surgery that does not involve thoracotomy (pure thoracoscopic surgery or VATS).
  • previous thoracotomy.
  • - Pathology affecting the chest wall (locally invasive lung cancer, empyema thoracis necessitans, intercostal neural lesions, pathological fractures rib).
  • - Surgery involving extensive involvement of the parietal pleura (such as pleurodesis, pleurectomy, extrapleural resection of the tumor).
  • - Closing technique with metallic suture points.

研究者

发起方
Javier E. Morales Sarabia

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