Spine Ultrasound Image Study of Spondylolisthesis Patient

Completed

• Conditions: Spondylolisthesis
• Interventions: Other: Spondylolisthesis

• Registration Number: NCT04426916
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-08
• Study First Submitted QC: 2020-06-08
• Study First Posted: 2020-06-11
• Study Start: 2020-06-23
• Primary Completion: 2020-08-06
• Study Completion: 2020-08-07
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-05
• Last Update Posted: 2021-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
spondylolisthesis	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..)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of