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

Sponsor

Yonsei University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04877964

Collaborator

(none)

Enrollment

Location

24.2

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to

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.
investigate the quality of ultrasound view for detecting ligamentum flavum and dura mater.

Condition or Disease	Intervention/Treatment	Phase
Scoliosis	Device: Ultrasound

Study Design

Study Type:

Observational

Anticipated Enrollment :

55 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jun 8, 2021

Anticipated Primary Completion Date :

Jun 8, 2023

Anticipated Study Completion Date :

Jun 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
pediatric patients with scoliosis Patients aged 3-14 years with scoliosis and who request epidural analgesia	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.

Arm

Intervention/Treatment

pediatric patients with scoliosis

Patients aged 3-14 years with scoliosis and who request epidural analgesia

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei University Health System, Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Yonsei University

Investigators

Principal Investigator: Hye Jin Kim, MD, Department of Anesthesiology and Pain Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT04877964

Other Study ID Numbers:

4-2021-0266

First Posted:

May 7, 2021

Last Update Posted:

May 10, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Scoliosis

Study Results

No Results Posted as of May 10, 2021