Detection of Intravascular Penetration During Cervical Transforaminal Epidural Block

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03040648

Enrollment

128

Registered

2017-02-02

Start date

2016-04-01

Completion date

2017-01-01

Last updated

2017-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnostic Imaging

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.

Interventions

DEVICEDSA

DSA was used for detection of intravascular injection

DEVICERTF

RTF was used for detection of intravascular injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The incidence of intravascular injection	4 seconds after injection of contrast media	The incidence of intravascular injection during cervical transforaminal block

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026