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Ultrasound Image Study for Ultrasound-assisted Paramedian Spinal Anesthesia

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ClinicalTrials.gov Identifier: NCT03929874
Recruitment Status : Completed
First Posted : April 29, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, 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.

Condition or disease
Anesthesia, Spinal Ultrasonography Sidedness Position

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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 2, 2019
Actual Primary Completion Date : June 19, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort
18 ≤ age ≤ 40
18 ≤ age ≤ 40
age ≥ 60
age ≥ 60



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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929874


Locations
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Korea, Republic of
Seoul national university hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jin-Tae Kim Kim, MD, PhD Seoul National University Hospital

Publications:
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Responsible Party: Jin-Tae Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03929874     History of Changes
Other Study ID Numbers: H-1903-110-1018
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No