Spine Ultrasound Image Study of Spondylolisthesis Patient

Spondylolisthesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426916
• Other study ID #: H-2005-149-1125
• Status: Completed
• Start date: June 23, 2020
• Est. completion date: August 7, 2020

Study information

• Verified date: January 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 7, 2020
• Est. primary completion date: August 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Spondylolisthesis

Intervention

Other:
• Spondylolisthesis
Spondylolisthesis at a single level

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Patients' gender, age, height, weight, BMI, etc.	gender, age, height, weight, BMI	Preanesthesia