Efficacy of caudal block with or without Dexamethasone as an adjuvant by using perfusion index as an indicator in paediatric patients undergoing infra-umbilical surgeries- A Randomized double-blind, controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in perfusion index (PI) after caudal block
研究概览
简要总结
Caudal block is used for pain relief in paediatric infraumbilical surgeries. Adding dexamethasone prolongs analgesia and improves perfusion. Perfusion Index, measured by pulse oximetry, serves as an early marker of block effectiveness. Children will undergo preanesthetic evaluation, consent, and premedication with IV midazolam. Standard monitoring will be applied, and anaesthesia induced with sevoflurane or propofol, along with fentanyl and muscle relaxant. After airway management, anaesthesia will be maintained with oxygen, Nitrous oxide, and sevoflurane. A caudal block will be performed: Group S will receive 0.125% Bupivacaine with saline, while Group D will receive 0.125% bupivacaine with 0.1mg/kg dexamethasone. Intraoperative monitoring of PI,HR, BP, oxygen saturation will be recorded every 15 minutes. Postoperatively, PI and hemodynamic parameters will be assessed at 3, 6, 9, and 12 hours, along with pain scores using the Faces Pain Scale.
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 10.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anaesthesiologists (ASA) physical status I, II and III
- •Age- 2 -10 yrs patients
- •Posted for elective infra umbilical surgeries (e.g., inguinal hernia repair, orchidopexy, circumcision, lower limb procedures) requiring caudal block.
排除标准
- •Suspected coagulopathy 2.Patients with severe peripheral vascular disease, Raynauds disease, or poor peripheral circulation.
- •Known allergy to drugs used in the study
- •Patients with infection at the site of caudal block, sacral bone abnormalities.
结局指标
主要结局
Change in perfusion index (PI) after caudal block
时间窗: baseline value, intraoperatively in intervals of 15 minutes and postoperatively at intervals of 3 hours, 6 hours, 9 hours and 12-hour.
次要结局
- Assess change in intraoperative heart rate, Blood pressure and Spo2 after caudal block(Intraoperatively every 15 mins and postoperative hemodynamic changes and postoperatively at intervals of 3 hours, 6 hours, 9 hours and 12-hours.)
- Post operative pain is observed using Face Pain Scale(At intervals of 3 hours, 6 hours, 9 hours and up to 12 hours)
研究者
Dr Shreja Saha
Kalinga Institute Of Medical Sciences