A randomized controlled study of Ultrasound guided novel sacral erector spinae block for postoperative analgesia in pediatric patients undergoing hypospadias repair at SMS Medical College, Jaipur.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- To assess postoperative analgesic (Paracetamol) consumption (in mgs) over 24 hours.
研究概览
简要总结
This randomzied controlled study is being conducted at SMS Medical College and attached Hospitals, Jaipur to evaluate efficacy of Ultrasound guided novel sacral erector spinae block for post operative analgesia in pediatric patients undergoing hypospadias repair . A total of 66 patients will be enrolled and randomized into two groups (Group A with block and Group B with no block). Parameters such as postoperative analgesic consumption, time to first rescue analgesic and pain assessment using FLACC score will be recorded at predefined time intervals. The aim is to assess whether Ultrasound guided novel sacral erector spinae block provide adequate postoperative analgesia, thereby supporting safer anesthetic practices of pain management in hypospadias repair surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients scheduled for elective hypospadias repair surgery.
- •Guardian willing to give informed written consent.
- •Patient of male sex with age group more than 2 years.
- •4.American Society of Anesthesiologists (ASA) physical status I-II.
排除标准
- •Patient should not be part of any other study.
- •Patient allergic to any drug given during procedure.
- •Patient with local site infection.
结局指标
主要结局
To assess postoperative analgesic (Paracetamol) consumption (in mgs) over 24 hours.
时间窗: 0,15,30 and 45 minutes, then 1,1.5,2,4,6,8,10,12,18 and 24 hours.
次要结局
- 1.To assess time to first rescue analgesic.
- 2.To assess postoperative pain using FLACC score.(0,15,30 and 45 minutes, then 1,1.5,2,4,6,8,10,12,18 and 24 hours.)
- 3. To assess side effects associated with block.(0,15,30 and 45 minutes, then 1,1.5,2,4,6,8,10,12,18 and 24 hours.)
研究者
Dr Varsha Kothari
SMS Medical College