Detection of Intravascular Penetration During Cervical Transforaminal Epidural Block

Not Applicable

Completed

• Conditions: Diagnostic Imaging
• Interventions: Device: RTF; Device: DSA

• Registration Number: NCT03040648
• Lead Sponsor: Kyungpook National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-01
• Primary Completion: 2016-12-30
• Status Verified: 2017-01
• Study Completion: 2017-01-01
• Study First Submitted: 2017-01-29
• Study First Submitted QC: 2017-01-31
• Last Update Submitted: 2017-01-31
• Study First Posted: 2017-02-02
• Last Update Posted: 2017-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
TFEB under RTF	RTF	cervical TFEB was performed under RTF
cervical TFEB under DSA	DSA	cervical TFEB was performed under DSA

Primary Outcome Measures

Name	Time	Method
The incidence of intravascular injection	4 seconds after injection of contrast media	The incidence of intravascular injection during cervical transforaminal block

Trial Locations

Locations (1)

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of