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
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