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Detection of Intravascular Penetration During Cervical Transforaminal Epidural Block

K

Kyungpook National University

Status

Completed

Conditions

Diagnostic Imaging

Treatments

Device: DSA
Device: RTF

Study type

Interventional

Funder types

Other

Identifiers

NCT03040648
KNUH 2016-05-039-001

Details and patient eligibility

About

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.

Enrollment

128 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

128 participants in 2 patient groups

cervical TFEB under DSA
Experimental group
Description:
cervical TFEB was performed under DSA
Treatment:
Device: DSA
TFEB under RTF
Active Comparator group
Description:
cervical TFEB was performed under RTF
Treatment:
Device: RTF

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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