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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03929874
Other study ID # H-1903-110-1018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2, 2019
Est. completion date June 30, 2019

Study information

Verified date July 2019
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This prospective observational study aimed to obtain ultrasound images for ultrasound-assisted paramedian spinal anesthesia and identify the differences according to sidedness of approach, position and age.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 30, 2019
Est. primary completion date June 19, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients under 40 or over 60 years of age who require spinal anesthesia for orthopedic surgery,

- with ASA physical status classification system I, II, III

Exclusion Criteria:

- Patients with contraindication to spinal anesthesia (coagulopathy, local infection, allergy to local anesthetic)

- Patients with communication difficulties

- Patient who can not take a sitting or lateral decubitus position (fracture)

- Patients with a history of spinal surgery

- Patient with anatomical abnormality of the spine

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Seoul national university hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Chin KJ, Perlas A, Chan V, Brown-Shreves D, Koshkin A, Vaishnav V. Ultrasound imaging facilitates spinal anesthesia in adults with difficult surface anatomic landmarks. Anesthesiology. 2011 Jul;115(1):94-101. doi: 10.1097/ALN.0b013e31821a8ad4. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Ultrasonic visualization grading at left L3-4, L4-5, L5-S1 interspace and right L3-4, L4-5, L5-S1 interspace in lateral decubitus position and sitting position Good: Both LFD (ligamentum flavum-dura mater complex) and PLL (posterior longitudinal ligament) are visible
Intermediate: Only one of LFD or PLL is visible
Poor: LFD and PLL are not visible
Preanesthesia
Primary Distance between the midline and the expected location of needle insertion Distance between the midline of the vertebrae and the expected location of needle insertion at left L3-4, L4-5, L5-S1 interspace and right L3-4, L4-5, L5-S1 interspace in lateral decubitus position and sitting position Preanesthesia
Primary Height of LFD through interlaminar space Height of LFD through interlaminar space visible in ultrasound image at left L3-4, L4-5, L5-S1 interspace and right L3-4, L4-5, L5-S1 interspace in lateral decubitus position and sitting position Preanesthesia
Primary Depth from skin to LFD The depth from skin to LFD at left L3-4, L4-5, L5-S1 interspace and right L3-4, L4-5, L5-S1 interspace in lateral decubitus position and sitting position Preanesthesia
Primary Depth from skin to PLL The depth from skin to PLL at left L3-4, L4-5, L5-S1 interspace and right L3-4, L4-5, L5-S1 interspace in lateral decubitus position and sitting position Preanesthesia
Primary Width of the intrathecal space The distance between the LFD and the PLL at left L3-4, L4-5, L5-S1 interspace and right L3-4, L4-5, L5-S1 interspace in lateral decubitus position and sitting position Preanesthesia
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