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Clinical Trials/NCT04877964
NCT04877964
Unknown
Not Applicable

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

Yonsei University1 site in 1 country55 target enrollmentJune 8, 2021
ConditionsScoliosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Scoliosis
Sponsor
Yonsei University
Enrollment
55
Locations
1
Primary Endpoint
the degree of agreement between the ultrasound-measured depth and the actual depth to the epidural space
Last Updated
4 years ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
June 8, 2021
End Date
June 15, 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

  • 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)

Outcomes

Primary Outcomes

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

Time Frame: 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)

Time Frame: 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

Study Sites (1)

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