NCT05132946Unknown不适用
Ultrasound-guided Erector Spinae Plane Block: A Comparative Study to Assess Its Analgesic Efficacy in Pediatric Patients Undergoing Aortic Coarctation Repair
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The number of times for usage of fentanyl in postoperative period
研究概览
简要总结
The study will include 40 patients who fulfil all the points in the inclusion and exclusion criteria will be randomized into two equal groups, each consisting of 20 patients, namely group (B) and group (C).
- Group (B): will receive erector spinae plane block.
- Group (C): will not receive any block. Postoperative pain score will be assessed using the FLACC scale or Face, Legs, Activity, Cry, Consolability scale immediately after extubation and at 1, 2, 4, 6, 8, 12, 18, and 24 hours. Routine postoperative analgesia in the form of intravenous paracetamol 7.5 mg/kg/6 hours will be given to all patients (the first dose is given after skin closure). Rescue analgesia in the form of 1 ug/kg fentanyl intravenously for patients if FLACC scale > 4, and the time for the first rescue analgesic administration will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All pediatric patients presented for aortic coarctation repair via left thoracotomy.
排除标准
- •Hypersensitivity to local anesthetic.
- •Mental or neurologic disorders.
- •Preoperative critically ill patients.
- •Parents or legal guardian refusal.
- •Infection at the site of injection.
- •Any liver disease.
- •Any coagulopathy.
结局指标
主要结局
The number of times for usage of fentanyl in postoperative period
时间窗: in the first 12 hours.
次要结局
未报告次要终点
研究者
samar mohammed
Lecturer of Anesthesia
Ain Shams University
研究点 (2)
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