Skip to main content
OpenTrials
Completed

NCT Number: NCT03929874

Ultrasound Image Study for Ultrasound-assisted Paramedian Spinal Anesthesia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia, Spinal Position Sidedness Ultrasonography

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul national university hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: 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

  2. Distance between the midline and the expected location of needle insertion

    Time frame: 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

  3. Height of LFD through interlaminar space

    Time frame: 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

  4. Depth from skin to LFD

    Time frame: 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

  5. Depth from skin to PLL

    Time frame: 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

  6. Width of the intrathecal space

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 29, 2019
Registry last updated
Jul 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.