Detection of Intravascular Penetration During Cervical Transforaminal Epidural Block

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2017-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Diagnostic Imaging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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cervical TFEB under DSA

cervical TFEB was performed under DSA

Group Type EXPERIMENTAL

DSA

Intervention Type DEVICE

DSA was used for detection of intravascular injection

TFEB under RTF

cervical TFEB was performed under RTF

Group Type ACTIVE_COMPARATOR

RTF

Intervention Type DEVICE

RTF was used for detection of intravascular injection

Interventions

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DSA

DSA was used for detection of intravascular injection

Intervention Type DEVICE

RTF

RTF was used for detection of intravascular injection

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No