Detection of Intravascular Penetration During Cervical Transforaminal Epidural Block

Diagnostic Imaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03040648
• Other study ID #: KNUH 2016-05-039-001
• Status: Completed
• Phase: N/A
• First received: January 29, 2017
• Last updated: January 31, 2017
• Start date: April 1, 2016
• Est. completion date: January 1, 2017

Study information

• Verified date: January 2017
• Source: Kyungpook National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: January 1, 2017
• Est. primary completion date: December 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diagnostic Imaging

Intervention

Device:
• DSA
DSA was used for detection of intravascular injection
• RTF
RTF was used for detection of intravascular injection

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University Hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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