Scoliosis Clinical Trial
Official title:
Ultrasound Measured Epidural Depth for Midline Approach in Pediatric Patients With Scoliosis: Prospective Observational Study
Verified date | May 2021 |
Source | Yonsei University |
Contact | Hye Jin Kim, MD |
Phone | 82-2-2224-4464 |
jackiedi[@]yuhs.ac | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Not yet recruiting |
Enrollment | 55 |
Est. completion date | June 15, 2023 |
Est. primary completion date | June 8, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 14 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Yonsei University Health System, Severance Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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