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

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.

Study Overview

• Status: Completed
• Conditions: Diagnostic Imaging
• Intervention / Treatment: Device: DSA; Device: RTF

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 700-721
    • Kyungpook National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: cervical TFEB under DSA; cervical TFEB was performed under DSA	Device: DSA; DSA was used for detection of intravascular injection
ACTIVE_COMPARATOR: TFEB under RTF; cervical TFEB was performed under RTF	Device: RTF; RTF was used for detection of intravascular injection

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kyungpook National University Hospital
• Investigators: Study Chair: Saeyoung Kim, MD, Kyungpook National University Hospital

Publications and helpful links

General Publications

• Jeon Y, Kim S. Detection of Intravascular Injection During Cervical Transforaminal Epidural Injection: A Comparison of Digital Subtraction Angiography and Real Time Fluoroscopy. Pain Physician. 2018 Mar;21(2):E181-E186.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2016
• Primary Completion (ACTUAL): December 30, 2016
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: January 29, 2017
• First Submitted That Met QC Criteria: January 31, 2017
• First Posted (ESTIMATE): February 2, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): February 2, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: KNUH 2016-05-039-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No