Comparison of Pudendal Nerve Block vs Caudal Block for Hypospadias Repair in Young Children: A Blinded Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Opioid consumption
研究概览
简要总结
The purpose of this randomized blinded prospective study is to compare the analgesic efficacy and duration of a Pudendal Nerve Block (PNB) to a Caudal Block (CB) for pediatric patients, ages 6 months to 2 years, undergoing hypospadias repair.
详细描述
Hypospadias repair is one of the most common congenital malformations of the penis in the United States. It has an incidence of about 1 in 300 births. A combination of general anesthesia and a caudal block or general anesthesia combined with a pudendal nerve block are commonly used for hypospadias repair.
In our institution, hypospadias repair is typically done in infants and children ages 6 months to age two. A comparison of the efficacy of pudendal block versus the caudal block has not been undertaken in this younger population.
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
No other parties will be masked.
入排标准
- 年龄范围
- 6 Months 至 2 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Boys undergoing hypospadias repair
排除标准
- 未提供
研究组 & 干预措施
Caudal block
1 cc per kg of 0.2% ropivacaine in the caudal space given before the start of surgery
干预措施: Caudal block (Procedure)
Bilateral Pudendal block
0.25 cc per kg of 0.2% ropivacaine will be injected once for right pudendal N block and the same volume for the left pudendal N block before the start of the surgery
干预措施: Bilateral Pudendal block (Procedure)
结局指标
主要结局
Opioid consumption
时间窗: up to 24 hours
The child's care giver will document the times that a rescue opioid was given to relieve pain.
次要结局
- Post operative pain(up to 2 hours)
- Intraoperative block assessment(up to 3 hours)