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

NCT ID: NCT04877964

Last Updated: 2021-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-08

Study Completion Date

2023-06-15

Brief Summary

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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

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Conditions

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Scoliosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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pediatric patients with scoliosis

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

Ultrasound

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

3 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hye Jin Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Pain Medicine

Locations

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Yonsei University Health System, Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Hye Jin Kim, MD

Role: CONTACT

82-2-2224-4464

References

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Choi YS, Jang J, Kim HY, Lee B, Kim EJ, Yoon HJ, Lee J, Kim HJ. Ultrasound estimates of the epidural depth in the paramedian sagittal oblique and transverse median planes: the correlation between estimated and actual depth to the epidural space in children with scoliosis. Reg Anesth Pain Med. 2024 Dec 2;49(12):883-888. doi: 10.1136/rapm-2023-105149.

Reference Type DERIVED
PMID: 38160017 (View on PubMed)

Other Identifiers

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4-2021-0266

Identifier Type: -

Identifier Source: org_study_id

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