Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants? A Multi-center Prospective Randomized Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Incidence of urethrocutaneous fistula
研究概览
简要总结
This is a prospective randomized multi-center non-inferiority trial conducted through the Pediatric Regional Anesthesia Network study sites to determine if caudal block increases the incidence of urethrocutaneous fistula following distal or mid shaft hypospadias repair compared with penile nerve block.
详细描述
Small retrospective series are in conflict about whether there is an association between caudal block and urethrocutaneous fistulas after hypospadias repair. The most common alternative to caudal blockade is a penile nerve block. The investigators will test the following hypothesis:
There is no difference in the incidence of urethrocutaneous fistula formation following single stage hypospadias repair with caudal anesthesia compared with penile nerve block.
The investigators will use a prospective randomized controlled design where subjects will receive either a caudal block or a penile nerve block to provide postoperative analgesia. Meatal anatomy will be graded by the urologist in the anesthetized child according to the HOPE (Hypospadias Objective Penile Evaluation) score, a validated scoring system. Both the total score and the individual component scores will be recorded. The operating urologist will determine the presence or absence of a fistula at the postoperative visit about 12 weeks after surgery, with subsequent follow up at 6 months and again at 12 months.
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
- None
入排标准
- 年龄范围
- 4 Months 至 2 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •infants/ children with midshaft or distal hypospadias undergoing primary single stage repair in one of the Pediatric Regional Anesthesia Network participating centers.
排除标准
- •prior hypospadias surgery,
- •proximal or penoscrotal hypospadias,
- •abnormal caudal anatomy or spinal dysraphism,
- •cyanotic congenital heart disease,
- •infection or rash at the block injection site.
研究组 & 干预措施
Caudal block
Patients will receive a caudal block with 0.75-1ml/kg of 0.2% ropivacaine.
干预措施: Caudal block with ropivacaine (Drug)
Penile Nerve Block
Patients will receive a dorsal penile nerve block with up to 0.75ml/kg of 0.25% bupivacaine.
干预措施: penile nerve block with bupivacaine (Drug)
结局指标
主要结局
Incidence of urethrocutaneous fistula
时间窗: 1 year
Presence of a urethrocutaneous fistula at postoperative visit up to 1 year after surgery.
次要结局
- Degree of efficacy of caudal block(1 hour after arrival in Post Anesthesia Care Unit (PACU) post surgery)
- Degree of pain(1 hour after arrival in PACU post surgery)
- Need for supplemental analgesics(1 hour after arrival in PACU post surgery)