A comparative study on the analgesic efficacy of ultrasound-guided bilateral pecto-intercostal fascial block with an ultrasound guided caudal block in pediatric patients undergoing congenital cardiac surgeries- A randomised double blind study.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- to assess additional fentanyl consumption in the intraoperative and postoperative period after extubation
研究概览
简要总结
There are no studies done on the effectiveness of ultrasound-guided caudal block and comparing it with ultrasound-guided Pecto-intercosto fascial block in pediatric cardiac surgical patients. Hence, we propose to compare the analgesic efficacy of U/S guided PIFB and caudal epidural block in children undergoing open heart surgery through a median sternotomy approach.
The primary outcome measure was to assess additional fentanyl consumption in the intraoperative and postoperative period after extubation within 12 hour between U/S guided PIFB versus U/S guided caudal block. The secondary outcome measure will be to assess pain scores in the postoperative period post exubation within 12 hours, duration of mechanical ventilation and the incidence of adverse effects between U/S guided PIFB versus U/S guided caudal block.
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
- 6.00 Month(s) 至 7.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients in the age group 6 months -7 years of age undergoing elective congenital cardiac surgery requiring median sternotomy and CPB will be included in the study.
排除标准
- •Patients with RACHS (Risk Adjusted classification for Congenital Heart Surgery) score > 3 b.
- •Emergency surgeries c.
- •Chest wall deformities d.
- •Anorectal malformations e.
- •Subjects allergic to local anaesthetics f.
- •Evidence of Coagulopathy g.
- •Patients on anticoagulants h.
- •Localized infection.
结局指标
主要结局
to assess additional fentanyl consumption in the intraoperative and postoperative period after extubation
时间窗: Within 12hours after extubation
次要结局
- To assess pain scores in the postoperative period post extubation, duration of mechanical ventilation and the incidence of adverse effects(Within 12hours)
研究者
Joshna valaji
Sri Padmavathi children heart centre, SVIMS university.