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Clinical Trials/NCT03040648
NCT03040648
Completed
Not Applicable

Detection of Intravascular Penetration During Cervical Transforaminal Epidural Block: a Comparison of Digital Subtraction Angiography and Real Time Fluoroscopy

Kyungpook National University Hospital1 site in 1 country128 target enrollmentApril 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diagnostic Imaging
Sponsor
Kyungpook National University Hospital
Enrollment
128
Locations
1
Primary Endpoint
The incidence of intravascular injection
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Transforaminal epidural block (TFEB) with local anesthetics and steroid is effective to treat spinal radicular pain. However, inadvertent intravascular injection can lead to severe neurologic complications. Digital subtraction angiography (DSA) during epidural block might increase the detection rate of intravascular penetration, compared to real-time fluoroscopy (RTF). But, DSA has disadvantages, such as additional radiation exposure to physicians and participants and the high cost of the new and upgraded fluoroscopic equipment. In this study, it was designed to compare DSA and RTF for detection of intravascular penetration in the same participant who underwent cervical TFEB.

The investigators prospectively examined the participants who received cervical TFEB. The needle position was confirmed using biplanar fluoroscopy and 2 ml of nonionic contrast media was injected at the rate of 0.5 ml/sec under RTF. Thirty seconds later, 2 ml of nonionic contrast media was injected at the rate of 0.5 ml/sec under DSA.

Registry
clinicaltrials.gov
Start Date
April 1, 2016
End Date
January 1, 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Younghoon Jeon

Professor

Kyungpook National University Hospital

Eligibility Criteria

Inclusion Criteria

  • participants with radiating pain from spinal stenosis and herniated nucleus pulposus.

Exclusion Criteria

  • pregnancy, allergic to contrast media, participants refusal, and participants with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.

Outcomes

Primary Outcomes

The incidence of intravascular injection

Time Frame: 4 seconds after injection of contrast media

The incidence of intravascular injection during cervical transforaminal block

Study Sites (1)

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