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

• Conditions: Scoliosis
• Interventions: Device: Ultrasound

• Registration Number: NCT04877964
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-29
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-07
• Last Update Submitted: 2021-05-07
• Last Update Posted: 2021-05-10
• Study Start: 2021-06-08
• Primary Completion: 2023-06-08
• Study Completion: 2023-06-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

1. 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pediatric patients with scoliosis	Ultrasound	Patients aged 3-14 years with scoliosis and who request epidural analgesia

Primary Outcome Measures

Name	Time	Method
the degree of agreement between the ultrasound-measured depth and the actual depth to the epidural space	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)	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

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of