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

Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04877964
• Other study ID #: 4-2021-0266
• Status: Not yet recruiting
• Start date: June 8, 2021
• Est. completion date: June 15, 2023

Study information

• Verified date: May 2021
• Source: Yonsei University
• Contact: Hye Jin Kim, MD
• Phone: 82-2-2224-4464
• Email: jackiedi[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 55
• Est. completion date: June 15, 2023
• Est. primary completion date: June 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 14 Years

Eligibility

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)

Related Conditions & MeSH terms

• Scoliosis

Intervention

Device:
• Ultrasound
Using ultrasound with transverse median and paramedian sagittal oblique approach, the screens that show the target epidural space in the center are obtained and stored for evaluation.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the degree of agreement between the ultrasound-measured depth and the actual depth to the epidural space	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.	Ultrasound image, which is obtained before epidural Touhy needle insertion, will be evaluated within 1 week after epidural Touhy needle insertion
Primary	the quality of ultrasound view for detecting ligamentum flavum and dura mater (in the transverse median and paramedian sagittal oblique plane)	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	Ultrasound image, which is obtained before epidural Touhy needle insertion, will be evaluated within 1 week after epidural Touhy needle insertion