- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05031936
: Intravascular Injection Rates During Cervical Medial Branch Block
Comparison of Intravascular Injection Rates During Cervical and Lumbar Medial Branch Block Using Touhy or Quincke Type Needle
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Daegu, Korea, Republic of, 42601
- Hong ji HEE
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- facet joint arthropathy
Exclusion Criteria:
- allergy to local anesthetics or contrast medium
- pregnancy
- spine deformity
- neurologic abnormality
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Touhy needle group
cervical medial branch block using touhy needle
|
spinal injections performed in cervical pillar area to relieve chronic neck pain
|
Placebo Comparator: Quincke needle group
cervical medial branch block using quincke needle
|
spinal injections performed in cervical pillar area to relieve chronic neck pain
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of intravascular injection
Time Frame: 1 minute after finishing cervical medial branch block
|
incidence of intravascular injection during cervical medial branch block
|
1 minute after finishing cervical medial branch block
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
time required to complete cervical medial branch block
Time Frame: Baseline, 1 second after the completion of cervical medial branch block
|
time required to complete cervical medial branch block
|
Baseline, 1 second after the completion of cervical medial branch block
|
radiation amout to complete cervical medial branch block
Time Frame: Baseline, 1 second after the completion of cervical medial branch block
|
radiation amout to complete cervical medial branch block
|
Baseline, 1 second after the completion of cervical medial branch block
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ji Hee Hong, Keimyung University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-07-014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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