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Clinical Trials/NCT04877964
NCT04877964UnknownNot Applicable

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

Yonsei University1 site in 1 country55 target enrollmentStarted: June 8, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
55
Locations
1
Primary Endpoint
the degree of agreement between the ultrasound-measured depth and the actual depth to the epidural space

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
3 Years to 14 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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