A Pilot Study of Smartphone -Based AI Assisted Ultrasound Guided Infraorbital Nerve Block in Pediatric Cleft Lip Repair : A Novel Low-cost Solution in Resource Limited Settings
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Infraorbital Nerve block Success rate measured by intraoperative fentanyl consumption
研究概览
简要总结
It's prospective single blinded randomized multi-center trial of 120 infant scheduled for primary unilateral cleft lip repair .
详细描述
The patients will be randomly allocated 1:1 into two groups; 60 patients in each group .AI assisted ultrasound - guided infraorbital nerve block and landmark based infraorbital nerve block.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 5 -18 months
- •Weight : 5-15 kilograms
- •ASA I - II
- •unilateral cleft lip repair
排除标准
- •less than 5 kilograms weight
- •Local infection at site of block
- •Coagulopathy
- •Parents refusal
研究组 & 干预措施
Arm 1:Smartphone -Based AI Assisted Ultrasound Guided Infraorbital Nerve Block
Smartphone -Based AI Assisted Ultrasound Guided Infraorbital Nerve Block in pediatric cleft lip repair
干预措施: Infraorbital Nerve Block (Procedure)
Arm 2 : Landmark based technique infraorbital nerve block
Landmark based technique infraorbital nerve block in pediatric cleft lip repair
干预措施: Infraorbital Nerve Block (Procedure)
结局指标
主要结局
Infraorbital Nerve block Success rate measured by intraoperative fentanyl consumption
时间窗: Surgical incision was allowed 10 minutes after block injection
FlACC pain score
时间窗: Every 6 hours postoperative for first 24 hours
FLACC pain score (Face, Legs, Activity, Cry, and Consolability) Lower score is 0 which means no pain Highest score is 10 which means severe pain
次要结局
未报告次要终点