Ultrasound Image Study for Ultrasound-assisted Paramedian Spinal Anesthesia

NCT03929874 | Completed

• 1 other identifier: H-1903-110-1018
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Spinal; Ultrasonography; Sidedness; Position

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

18 ≤ age ≤ 40

18 ≤ age ≤ 40

age ≥ 60

age ≥ 60

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients under 40 orover 60 years of age who require spinal anesthesia for orthopedic surgery, with ASA physical status classification system I, II, III

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul national university hospital

Seoul, 03080, South Korea

Location

Related Publications (2)

• 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.

  PMID: 21572316 BACKGROUND

• Bae J, Park SK, Yoo S, Lim YJ, Kim JT. Influence of age, laterality, patient position, and spinal level on the interlamina space for spinal puncture. Reg Anesth Pain Med. 2019 Nov 4:rapm-2019-100980. doi: 10.1136/rapm-2019-100980. Online ahead of print.

  PMID: 31690644 DERIVED

Study Officials

• Jin-Tae Kim Kim, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: April 29, 2019
• Study Start: May 2, 2019
• Primary Completion: June 19, 2019
• Study Completion: June 30, 2019
• Last Updated: July 11, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)