跳至主要内容
临床试验/NCT04877964
NCT04877964Unknown不适用

Ultrasound Measured Epidural Depth for Midline Approach in Pediatric Patients With Scoliosis: Prospective Observational Study

Yonsei University1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2021年6月8日最近更新:
适应症

试验速览

阶段
不适用
入组人数
55
试验地点
1
主要终点
the degree of agreement between the ultrasound-measured depth and the actual depth to the epidural space

研究概览

简要总结

The purpose of this study was to

  1. investigate the degree of agreement between the ultrasound-measured depth (in the transverse median and paramedian sagittal oblique plane) and the actual depth to the epidural space in pediatric patients with scoliosis.
  2. investigate the quality of ultrasound view for detecting ligamentum flavum and dura mater.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • pediatric patients (aged 3-14 years) with scoliosis (cobb angle >10 degree) scheduled for correctional osteotomy of the lower extremity and requesting epidural analgesia for postoperative pain control

排除标准

  • Contraindications to epidural analgesia (local infection, blood clotting disorder, anatomical abnormality, sepsis, etc.)
  • If all of the parents of the subject are foreigners or illiterate (if the parents of the subject can not read the agreement)

结局指标

主要结局

the degree of agreement between the ultrasound-measured depth and the actual depth to the epidural space

时间窗: Ultrasound image, which is obtained before epidural Touhy needle insertion, will be evaluated within 1 week after epidural Touhy needle insertion

the degree of agreement between the ultrasound-measured depth (in the transverse median and paramedian sagittal oblique plane) and the actual depth to the epidural space in pediatric patients with scoliosis.

the quality of ultrasound view for detecting ligamentum flavum and dura mater (in the transverse median and paramedian sagittal oblique plane)

时间窗: Ultrasound image, which is obtained before epidural Touhy needle insertion, will be evaluated within 1 week after epidural Touhy needle insertion

the quality of ultrasound view for detecting ligamentum flavum and dura mater (in the transverse median and paramedian sagittal oblique plane). Good: The distinction is clear and visible Fair: Visible by adjusting the probe Poor: Observation is difficult even when the probe is adjusted

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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