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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.

Ultrasound Image Study for Ultrasound-assisted Paramedian Spinal Anesthesia

Clinicaltrials.gov identifier NCT03929874

Recruitment Status Completed

First Posted April 29, 2019

Last update posted July 11, 2019

Study Description

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.

  • Condition or Disease:Position
    Anesthesia, Spinal
    Ultrasonography
    Sidedness
  • Intervention/Treatment:
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Actual Enrollment: 40 participants
  • Observational Model: Case-Only
  • Time Perspective: Prospective
  • Official Title: Ultrasound Image Study for Ultrasound-assisted Paramedian Spinal Anesthesia: Difference in Sidedness of Approach, Position and Age
  • Actual Study Start Date: May 2019
  • Actual Primary Completion Date: June 2019
  • Actual Study Completion Date: June 2019
Outcome Measures
  • Primary Outcome Measures: 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
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • 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
Criteria

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

Contacts and Locations
Contacts
Locations

Korea, Republic of
Seoul national university hospital
Seoul

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator: Jin-Tae Kim Kim, MD, PhD Seoul National University Hospital

More Information