Comparison of Post-surgical versus Pre-surgical caudal block on surgical outcomes in children undergoing hypospadias repair:A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Overall incidence of the following surgical complications: Urethro-cutaneous fistula, Local skin necrosis, Wound infection, Hematoma, Glans dehiscence and urethral stricture
研究概览
简要总结
The Aim of the study is to compare the effect of post-surgical versus pre-surgical caudal blocks on surgical complications in children undergoing hypospadias repair surgery.Patient included are all ASA1 and ASA II ages 1 to 8 years. After approval from institutional ethics committee and obtaining written informed consent patient included in the study will be randomised to receive caudal blocks. There will be 2 groups one group will be receiving caudal blocks post-surgically and will be compared to the groups receiving caudal blocks pre-surgically.Primary surgical outcomes and complications, and secondary anaesthetic peri-operative outcomes will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male child:Aged 1-8 years ASA I and II children undergoing hypospadias repair surgery.
排除标准
- •skin infection or abscess at the side of caudal injection parents disagreement / refusal to consent patients having coagulopathy / on anticoagulants known allergy to any local anaesthetics children with neuromuscular disorders spinal dysraphism(meningomyelocele/sacral dimples) mental retardation/delayed development.
结局指标
主要结局
Overall incidence of the following surgical complications: Urethro-cutaneous fistula, Local skin necrosis, Wound infection, Hematoma, Glans dehiscence and urethral stricture
时间窗: Post operative: Day 5, Day 10, 1 month and 6 months
次要结局
- Intra-operative blood loss(At the end of surgery)
- Intra-operative increase in penile volume(0,10,15 & 30 minutes post induction of anesthesia)
- Surgical stress response [blood glucose, by point of care glucometer](0,30,60 & 90 minutes post induction)
- Surgery duration(End of surgery)
- Surgery revision rate (requirement of re-surgery)(Ascertained at 1 & 6 months post operative)
- Duration of post-operative analgesia(Post operative, the time to first rescue analgesic requirement at a FLACC score more than 5 or Visual Analogue Score corresponding to Numerical rating scale of more than 5 (in older children).)
研究者
Dr Osharani Rathor
All India Institute of Medical Sciences Rishikesh