Randomized Clinical Trial to Evaluate the Superiority on the Decrease the Consumption of Fentanyl the First 48 Hours of Bilateral Serratus Intercostal Plane Block in Myocardial Revascularization Surgery by Sternotomy.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Fentanyl Consume
研究概览
简要总结
Two-parallel arm, double-blind, individually randomized controlled trial.
Primary endpoint:
Fentanyl consumption in the first 48 postoperative hours.
Secondary endpoints:
Pain at rest, Pain on movement, stay in ICU, Postoperative nausea and vomiting (PONV), sedation, Hemothorax, seizures, arrythmias
详细描述
Trial design: Two-parallel arm, double-blind, individually randomized controlled trial.
Primary endpoint:
Fentanyl consumption in the first 48 postoperative hours.
Secondary endpoints:
Pain at rest, Pain on movement, stay in ICU, Postoperative nausea and vomiting (PONV), sedation, Hemothorax, seizures, arrythmias
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participant: The Patients will not know about intervention group they will be. Care Provider : The medical, nursing and pain clinical will not know the group to which the patient belongs Outcomes Assessor: during the analysis the staff will not know which group the patient belong
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient between 18 years to 80 years
- •Patient to myocardial revascularization by sternotomy
排除标准
- •Patient for combined surgery ( myocardial revascularization by sternotomy plus valve or maze)
- •Emergency surgery
- •Ejection Fraction less than 35%
- •Allergy to the local anesthesics.
- •Allergy to opioids
- •Patient in who will be technically impossible the application of the blockade
结局指标
主要结局
Fentanyl Consume
时间窗: 48 hours
Microgrames of Fentanyl that patient consume during the first 48 hours in the postoperative
次要结局
- hemothorax(24 hours)
- Nausea and vomiting(48 hours.)
- Pain In Rest and in motion(48 hours)
- Sedation(48 hours.)
- seizures(1 hour after block)
- Arrhythmias(1 hour after block)