A Comparison of Effectiveness of Pudendal Nerve Block vs Caudal Block for Hypospadias Surgery in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- postoperative pain intensity measure
研究概览
简要总结
The aim of this prospective randomized study is to assess the analgesic efficacy and duration of Pudendal block compared with Caudal block for pediatric patients undergoing hypospadias surgery concerning intraoperative analgesic and also postoperative total analgesic consumption within 24 hours.
详细描述
In this prospective study, patients will be randomized into 2 groups, either receiving Caudal Block(CB) or nerve stimulator-guided Pudendal Nerve Block(PNB). Analgesic consumption will be assessed during the first 24 hours postoperatively. The "CHEOPS pain scale" will use to assess postoperative pain.
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
- Single (Investigator)
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-II
- •aged 1 to 10 years scheduled undergoing hypospadias surgery
排除标准
- •history of allergic reactions to local anesthetics
- •rash or infection at the injection site
- •anatomical abnormality
- •bleeding diatheses, coagulopathy, liver diseases
结局指标
主要结局
postoperative pain intensity measure
时间窗: 24 hours
pain scores are recorded (postoperative within 24 hours) the investigators use CHEOPS pain scale for evaluation pain intensity. When pain score is 7 or higher than 7, pain treatment is evaluated as inadequate.
次要结局
- time to to first use of analgesic(24 hours)
- the incidence of side effects(24 hours)
- postoperative total analgesic requirements(24 hours)
- parental satisfaction(24 hours)
- intraoperative analgesic requirement(intraoperative)
研究者
pinar kendigelen
M.D.(Anesthesiology Specialist)
Istanbul University