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NCT Number: NCT04426916

Spine Ultrasound Image Study of Spondylolisthesis Patient

This study is to evaluate the anatomical characteristics of spondylolisthesis patients using spine ultrasound imaging. The optimal angle of spinal needle insertion for spinal anesthesia in spondylolisthesis patients was compared to that of normal patients without abnormal spinal anatomy.

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Key information

Conditions

Spondylolisthesis Bone Diseases Musculoskeletal Diseases Spinal Diseases Spondylolysis Spondylosis

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients scheduled for elective orthopedic surgery.
  • with ASA physical status classification system I, II, III.

Exclusion criteria

  • Patients with communication difficulties.
  • Patient who can not take a lateral decubitus position for spinal anesthesia. (e.g) fracture)
  • Patients with a medical history of spinal surgery.
  • Patients with significant spinal anatomical deformity any other than spondylolisthesis. (for spondylolisthesis patients group)

Treatment and study plan

Spondylolisthesis

Other

Spondylolisthesis at a single level

Primary outcomes

  1. The predicted optimal angle of spinal needle insertion for spinal anesthesia at the level of spondylolisthesis. (alpha 1)

    Time frame: Preanesthesia

    The needle insertion angle where the height of ligamentum flavum/dura mater complex(LFD) is measured the longest in ultrasound image.

  2. The predicted optimal angle of spinal needle insertion for spinal anesthesia at the one upper level of spondylolisthesis. (alpha 2)

    Time frame: Preanesthesia

    The needle insertion angle where the height of LFD is measured the longest in ultrasound image.

Secondary outcomes

  1. The height of LFD measured by ultrasound image.

    Time frame: Preanesthesia

    The height of LFD at the interlaminar space in midline and paramedian ultrasonography view at the angle of alpha 1 & alpha 2.

  2. The depth from skin (needle insertion point) to LFD.

    Time frame: Preanesthesia

    The depth from skin to LFD at the interlaminar space in midline and paramedian ultrasonography view at the angle of alpha 1 & alpha 2.

  3. The depth from skin (needle insertion point) to posterior longitudinal ligament(PLL).

    Time frame: Preanesthesia

    The depth from skin to PLL at the interlaminar space in midline and paramedian ultrasonography view at the angle of alpha 1 & alpha 2.

  4. Patients' gender, age, height, weight, BMI, etc.

    Time frame: Preanesthesia

    gender, age, height, weight, BMI

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Ultrasound Image Study to Evaluate the Optimal Angulation of Needle Insertion for Spinal Anesthesia in Patients With Spondylolisthesis

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 11, 2020
Registry last updated
Jan 7, 2021

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.

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