Comparison of ultrasound-guided pudendal nerve block (PNB) versus caudal epidural block (CEB) on surgical outcomes in children undergoing hypospadias surgery: a parallel arm randomized control study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Urethrocutaneous fistula,
研究概览
简要总结
General anesthesia along with caudal epidural block (CEB) is commonly used in children undergoing hypospadias surgery.Significant increase in the incidence of urethrocutaneous fistula have been reported by many studies in children who underwent hypospadias surgery.CEB results in the sympathetic blockade, venous pooling & penile engorgement. This may influence the quality of repair & impaired wound healing. Thus, may lead to an increased incidence of urethrocutaneous fistula along with other negative surgical outcomes. Pudendal nerve block (PNB) provides analgesia for perineum and external genitalia surgery. PNB has no sympathetic blockade like that of CEB.Hence this study aims to find out whether PNB shall result in lesser postoperative surgical complications in children undergoing hypospadias surgery as compared to CEB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.ASA grade I and II patients 2.Male children aged between 03years -12 years of age scheduled for hypospadias repair.
排除标准
- •1.Children with a bleeding disorder 2.Redo urethroplasty 3.Contraindication to CEB 4.Vertebral column anomaly 5.Neurological disorders 6.Refusal of the parents for regional blocks.
结局指标
主要结局
Urethrocutaneous fistula,
时间窗: The duration of follow-up shall be till 14 days or up to the removal of the urinary catheter, whichever is earliest. Reporting of any one or more of these complications by the operating surgeon, shall be recorded as “Yes†& if none of them are reported shall be recorded as “No
Wound dehiscence, Wound infection, Skin necrosis, Flap necrosis
时间窗: The duration of follow-up shall be till 14 days or up to the removal of the urinary catheter, whichever is earliest. Reporting of any one or more of these complications by the operating surgeon, shall be recorded as “Yes†& if none of them are reported shall be recorded as “No
To report post-operative surgical complications such as
时间窗: The duration of follow-up shall be till 14 days or up to the removal of the urinary catheter, whichever is earliest. Reporting of any one or more of these complications by the operating surgeon, shall be recorded as “Yes†& if none of them are reported shall be recorded as “No
次要结局
- Modified objective pain scores (MOPS) on arrival in the post-anesthesia care unit, 2,6,12,24 & 48 hours after surgery, Time to administration first rescue analgesia, The total dose and number of rescue analgesia (Inj. Tramadol) required in the first 48 hours of surgery.