Ultrasound Image Study for Ultrasound-assisted Paramedian Spinal Anesthesia

Completed

• Conditions: Anesthesia, Spinal; Position; Sidedness; Ultrasonography

• Registration Number: NCT03929874
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-29
• Study Start: 2019-05-02
• Primary Completion: 2019-06-19
• Study Completion: 2019-06-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	Preanesthesia	* 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
Distance between the midline and the expected location of needle insertion	Preanesthesia	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
Height of LFD through interlaminar space	Preanesthesia	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
Depth from skin to LFD	Preanesthesia	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
Depth from skin to PLL	Preanesthesia	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
Width of the intrathecal space	Preanesthesia	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

Trial Locations

Locations (1)

Seoul national university hospital; 🇰🇷 Seoul, Korea, Republic of