Evaluation of Ultrasound Guided Modified Pectoral Nerves Blocks in Transvenous Subpectoral Pacemaker Insertion in Children: Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mean Post-operative pain score by The Face, Legs, Activity, Cry, Consolability scale (FLACC) scale.
研究概览
简要总结
Evaluation of Ultrasound Guided Modified Pectoral Nerves Blocks in Transvenous Subpectoral pacemaker insertion in Children: Randomized Controlled Trial
详细描述
BACKGROUND Pectoral nerve blocks (PECs) can reduce intraprocedural anesthetic requirements and postoperative pain. Little is known about the utility of PECs in reducing pain and narcotic use after pacemaker (PM)placement in children. OBJECTIVE The purpose of this study was to determine whether PECs can decrease postoperative pain and opioid use after PM placement in children.
METHODS A single-center controlled trial of pediatric patients undergoing transvenous PM placement between 2020 and 2021 will be performed. Demographics, procedural variables, postoperative pain, and postoperative opioid usage will be compared between patients who undergone PECs and those who undergone conventional anesthetic (Control).
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
- Double (Participant, Care Provider)
盲法说明
An online randomization program (http://www.randomizer.org) will be used to generate random list and to allocate patients into two study groups: Random allocation numbers will be concealed in opaque closed envelops. The patient and investigator performing the block and assessing study outcomes will all be blinded to the study group allocation.
入排标准
- 年龄范围
- 1 Year 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •congenital or post-operative heart block.
排除标准
- •⦁ Redo patient
- •History of allergic reactions to local anesthetics.
- •Bleeding disorders with International Normalization Ratio( INR) > 1.5 and/or platelets < 50
- •Rash or signs of infection at the injection site.
- •Emergency procedure
研究组 & 干预措施
control
conventional control group(C) (n=20) where20 children will receive IV paracetamol 20 mg / kg and atracurium top ups at a dose of 0.1mg/kg. every 30 minutes.
干预措施: paracetamol (Drug)
PECs
Pectoral nerves blocks group (P) (n=20) where 20 children will have PECs Block and atracurium top ups upon request.
干预措施: modifiedPECs block (Procedure)
结局指标
主要结局
Mean Post-operative pain score by The Face, Legs, Activity, Cry, Consolability scale (FLACC) scale.
时间窗: immediate, 6,12 ,18 and 24 hours after intervention
pain score
次要结局
- Total consumption of opioids.(immediate, 6,12 ,18 and 24 hours after intervention)
研究者
Ahmed Mohamed Mohamed Elhaddad
lecturer
Kasr El Aini Hospital