Detection of Intravascular Penetration During Cervical Transforaminal Epidural Block

NCT03040648 | Completed DMC

• 1 other identifier: KNUH 2016-05-039-001
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Diagnostic Imaging

Outcome Measures

Primary Outcomes (1)

• The incidence of intravascular injection

  The incidence of intravascular injection during cervical transforaminal block

  4 seconds after injection of contrast media

Study Arms (2)

cervical TFEB under DSA

EXPERIMENTAL

cervical TFEB was performed under DSA

Device: DSA

TFEB under RTF

ACTIVE COMPARATOR

cervical TFEB was performed under RTF

Device: RTF

Interventions

DSA DEVICE

DSA was used for detection of intravascular injection

cervical TFEB under DSA

RTF DEVICE

RTF was used for detection of intravascular injection

TFEB under RTF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• participants with radiating pain from spinal stenosis and herniated nucleus pulposus.

You may not qualify if:

• pregnancy, allergic to contrast media, participants refusal, and participants with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.

Sponsors & Collaborators

• Kyungpook National University Hospital: lead

Study Sites (1)

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

Related Publications (1)

• 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.

  PMID: 29565961 DERIVED

Study Officials

• Saeyoung Kim, MD

  Kyungpook National University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2017
• First Posted: February 2, 2017
• Study Start: April 1, 2016
• Primary Completion: December 30, 2016
• Study Completion: January 1, 2017
• Last Updated: February 2, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)