EUCTR2019-003855-12-ES进行中（未招募）1 期
Phase III Clinical Trial, single-center, randomized, double-blind, to demonstrate a lower incidence of acute diaphragmatic paralysis of the brachial plexus block with interscalene approach in arthroscopic shoulder surgery after administration of 25 mg of 0.25% Levobupivacaine compared to 50 mg administration
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
- 48
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
- •1. Written informed consent to participate in the clinical trial.
- •2. Be intervened with scheduled arthroscopic shoulder surgery.
- •3. Age between 18 and 80 years old,
- •4. ASA I-III.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1. Allergic to local amide type anesthetics, opioids or nonsteroidal anti-inflammatory drugs.
- •2. Non-acceptance for the realization of the BBPAI.
- •3. Contraindication for the realization of the BPBAI,
- •4. Contraindication for performing a spirometry.
- •5. History of pulmonary pathology: moderate or severe COPD, or unstable asthma.
- •6. Previous diaphragmatic paralysis or other neuromuscular pathology with respiratory involvement,
- •7. Pregnancy
- •8. Coagulation disorders (INR> 3, TTPA> 35 and AP <50%).
- •9. Brachial plexus neuropathy.
- •10. Chronic opioid consumption: defined as the administration of opioids for more than 3 months or equivalent to more than 5 mg daily of VO Morphine for 1 month.
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