Ultrasound Image Study for Ultrasound-assisted Paramedian Spinal Anesthesia

Ultrasonography Clinical Trial

Official title:

Ultrasound Image Study for Ultrasound-assisted Paramedian Spinal Anesthesia: Difference in Sidedness of Approach, Position and Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03929874
• Other study ID #: H-1903-110-1018
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Anesthesia, Spinal
• Position
• Sidedness
• Ultrasonography

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