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

NCT04877964 | Unknown

• 1 other identifier: 4-2021-0266
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to

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

Conditions

Scoliosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

pediatric patients with scoliosis

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

Device: Ultrasound

Interventions

Ultrasound 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.

pediatric patients with scoliosis

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \. 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 38160017 DERIVED

MeSH Terms

Conditions

Scoliosis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Hye Jin Kim, MD

  Department of Anesthesiology and Pain Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hye Jin Kim, MD

CONTACT

82-2-2224-4464; jackiedi@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 7, 2021
• Study Start: June 8, 2021
• Primary Completion: June 8, 2023
• Study Completion: June 15, 2023
• Last Updated: May 10, 2021

Record last verified: 2021-05

Locations

KR (1)