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Detection of Intravascular Penetration During Cervical Transforaminal Epidural Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040648
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Younghoon Jeon, Kyungpook National University

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.


Condition or disease Intervention/treatment Phase
Diagnostic Imaging Device: DSA Device: RTF Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Detection of Intravascular Penetration During Cervical Transforaminal Epidural Block: a Comparison of Digital Subtraction Angiography and Real Time Fluoroscopy
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : December 30, 2016
Actual Study Completion Date : January 1, 2017

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




Primary Outcome Measures :
  1. The incidence of intravascular injection [ Time Frame: 4 seconds after injection of contrast media ]
    The incidence of intravascular injection during cervical transforaminal block



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040648


Locations
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Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of, 700-721
Sponsors and Collaborators
Kyungpook National University
Investigators
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Study Chair: Saeyoung Kim, MD Kyungpook National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Younghoon Jeon, Professor, Kyungpook National University
ClinicalTrials.gov Identifier: NCT03040648    
Other Study ID Numbers: KNUH 2016-05-039-001
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No