Rates of urethrocutaneous fistula/ glans dehiscence among children undergoing urethroplasty under GA with caudal morphine and local anaesthetic or caudal morphine and normal saline.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Rates of urethrocutaneous fistula/ glans dehiscence
研究概览
简要总结
Urethroplasty is a common procedure done for hypospadias in children with aim of providing a normal meatus at the tip for voiding. This procedure is done under general anaesthesia +/- caudal analgesia which takes care of the pain during and after the surgery. Postoperatively when children are followed up, it is seen that some of the children have surgical complications like Urethrocutaneous fistula (UCF), glans dehiscence, meatal stenosis, etc. Various studies have shown that caudal analgesia is associated with surgical complications like UCF and glanular dehiscence. In this prospective study, we are trying to see if caudal analgesia is directly associated with above mentioned surgical complications. Children who are diagnosed with hypospadias and will undergo urethroplasty will be included in the study. Consent will be taken from the parents after explaining the plan of Anaesthesia during surgery. Children will be randomly allocated into two different groups. Children of both the groups will be operated under General Anaesthesia. After randomisation, one set of children will get caudal analgesia with 0.2% Ropivacaine + 30mcg/kg Caudal morphine and another set of children will get caudal analgesia with 0.9% NS + 30mcg/Kg Caudal morphine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Year(s) 至 16.00 Year(s)(—)
- 性别
- All
入选标准
- •Children more than 1 year and less than age of 16 years
- •Primary urethroplasty.
排除标准
- •1.Staged procedures.
- •2.Redo surgeries.
- •3.Severe hypospadias (seen in DSD, CHD etc) 4.Children with contraindications for caudal analgesia like sepsis, local site infection, bleeding disorders, etc.
- •5.Children less than 1 year.
结局指标
主要结局
Rates of urethrocutaneous fistula/ glans dehiscence
时间窗: 4-8 weeks post operatively.
次要结局
- 1.Intra operative penile girth measurement.(2.Peri-operative opioid requirement.)
