Spine Ultrasound Image Study of Spondylolisthesis Patient

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

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.

Study Overview

• Status: Completed
• Conditions: Spondylolisthesis
• Intervention / Treatment: Other: Spondylolisthesis

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients scheduled for elective orthopedic surgery in SNUH(Seoul national university hospital) with ASA physical status classification system I, II, III.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
normal lumbar spine; Patient without spondylolisthesis or significant spinal anatomic deformity. (ex> severe spondylosis, spinal stenosis, scoliosis, etc..)
spondylolisthesis; Spondylolisthesis patients, with whom the deformity is at just one level. The patients should not have any other significant spinal deformity. (ex> severe spondylosis, spinal stenosis, scoliosis, etc..)	Other: Spondylolisthesis; Spondylolisthesis at a single level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The predicted optimal angle of spinal needle insertion for spinal anesthesia at the level of spondylolisthesis. (alpha 1)	The needle insertion angle where the height of ligamentum flavum/dura mater complex(LFD) is measured the longest in ultrasound image.	Preanesthesia
The predicted optimal angle of spinal needle insertion for spinal anesthesia at the one upper level of spondylolisthesis. (alpha 2)	The needle insertion angle where the height of LFD is measured the longest in ultrasound image.	Preanesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The height of LFD measured by ultrasound image.	The height of LFD at the interlaminar space in midline and paramedian ultrasonography view at the angle of alpha 1 & alpha 2.	Preanesthesia
The depth from skin (needle insertion point) to LFD.	The depth from skin to LFD at the interlaminar space in midline and paramedian ultrasonography view at the angle of alpha 1 & alpha 2.	Preanesthesia
The depth from skin (needle insertion point) to posterior longitudinal ligament(PLL).	The depth from skin to PLL at the interlaminar space in midline and paramedian ultrasonography view at the angle of alpha 1 & alpha 2.	Preanesthesia
Patients' gender, age, height, weight, BMI, etc.	gender, age, height, weight, BMI	Preanesthesia

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• Kim Y, Yoo S, Park SK, Bae H, Lim YJ, Kim JT. Optimal angle of needle insertion for spinal anesthesia in patients with spondylolisthesis: an ultrasonographic study. BMC Anesthesiol. 2021 Sep 8;21(1):221. doi: 10.1186/s12871-021-01444-0.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 23, 2020
• Primary Completion (ACTUAL): August 6, 2020
• Study Completion (ACTUAL): August 7, 2020

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (ACTUAL): June 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 7, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: optimal angle
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: H-2005-149-1125

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No