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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05031936
Other study ID # 2021-07-014
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 12, 2021
Est. completion date October 30, 2022

Study information

Verified date December 2022
Source Keimyung University Dongsan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare using Toughy needle has an advantage of reducing intravascular injection rates during cervical medial branch block.


Description:

In previous reports, the use of Toughy needle was thought to reduce the incidence of intravascular injection as low as 2.9% during lumbar transforaminal injection. Blunt needles with a pencil point tip, such as Whitacre needles, are not as sharp at their tip as are Quincke needles, which have bevels. Toughy or blunt needles may therefore be less likely to penetrate a vessel during a procedure. Hence, we postulated the incidence of intravenous uptake would be significantly lower using a Toughy needle than using a Quincke needle for lumbar medial branch block. To confirm the intravascular injection rates, we used the real time fluoroscopy after injection of contrast medium. The goal of this study was to compare the incidence of intravascular injection rate betweeen Toughy and Quincke needles using real time fluoroscopy during cervical medial branch block


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date October 30, 2022
Est. primary completion date October 30, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 79 Years
Eligibility Inclusion Criteria: - facet joint arthropathy Exclusion Criteria: - allergy to local anesthetics or contrast medium - pregnancy - spine deformity - neurologic abnormality

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
cervical spinal injection with 0.2% ropivacaine
spinal injections performed in cervical pillar area to relieve chronic neck pain

Locations

Country Name City State
Korea, Republic of Hong ji HEE Daegu

Sponsors (1)

Lead Sponsor Collaborator
Keimyung University Dongsan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary incidence of intravascular injection incidence of intravascular injection during cervical medial branch block 1 minute after finishing cervical medial branch block
Secondary time required to complete cervical medial branch block time required to complete cervical medial branch block Baseline, 1 second after the completion of cervical medial branch block
Secondary radiation amout to complete cervical medial branch block radiation amout to complete cervical medial branch block Baseline, 1 second after the completion of cervical medial branch block
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