A Randomized Controlled Trial of Sacral Erector Spinae Block Versus Caudal Block for Postoperative Analgesia After Hypospadias Surgery in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 3
- 主要终点
- Number of analgesic consumption
研究概览
简要总结
The purpose of this research study is to find the best way to decrease pain in children whom have had hypospadias surgery. Investigators will perform two technique; Caudal block or Sacral erector spinae block.
The results of this study will help learn how to best control pain in children having surgery hypospadias surgery.
详细描述
Children aged 1-9 years undergoing hypospadias surgeries would be recruited in this randomized study.
Children would be monitored by electrocardiogram, pulse oximeter and non-invasive blood pressure.
After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory (jaw relaxed, lash reflex disappeared, no coughing, gagging, swallowing).After ethical committee approval, informed written consent will be obtained from all patients.
Consenting patients scheduled to have hypospadias surgery will be randomised to sacral erector spinae block or caudal block at the begin of surgery.
All patients heart rate,MAP and Oxygen saturation record intraoperatively. All patients will receive paracetamol if requirement for postoperative analgesia.All patient will transfer from PACU to day-surgery unit (DSU) if they achieved Modified Aldrete Score of ten.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 9 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-II
- •Undergoing unilateral low abdominal surgery
排除标准
- •History of developmental delay or mental retardation, which will make observational pain intensity assessment difficult
- •Parent refusal
- •History of allergic reactions to local anesthetics
- •Rash or infection at the injection site
- •Anatomical abnormality
- •Bleeding diatheses
- •Coagulopathy
- •History of diseases renal hepatic cardiac upper or lower airway neurologica
结局指标
主要结局
Number of analgesic consumption
时间窗: 24 hour
Acetaminophen and Fentanly
次要结局
- Face, Legs, Activity, Cry and Consolability Score (FLACC)(24 hour)
- Parent satisfaction scores(24 hour)
研究者
Gözen Öksüz
Assistant Professor
Kahramanmaras Sutcu Imam University