Detection of Intravascular Injection Between Blunt and Sharp Needles During Cervical Transforaminal Epidural Block.

Not Applicable

Completed

• Conditions: Pain; Radicular; Neuropathic, Cervical
• Interventions: Procedure: block with Blunt-type block needle.; Procedure: block with sharp-type block needle.

• Registration Number: NCT03286946
• Lead Sponsor: Kyungpook National University Hospital

Brief Summary

This study evaluates the incidence of intravascular injection during cervical transforaminal epidural block using blunt needle, compared to the sharp needle. The investigators will performed cervical transforaminal epidural block using blunt-type block needle in half of participants or sharp-type block needle in the other half.

Detailed Description

Cervical transforaminal epidural block is an effective treatment option of radiating pain. There are potential risks associated with transforaminal epidural block such as infection, dural puncture, bleeding, and intravascular injection. Although the risk is low, intravascular injection should be carefully monitored because intravascular injection of particulate steroids can cause fatal neurologic deficits such as spinal infarction and cerebral infarction.

The incidence of intravascular injection during transforaminal epidural block with real time fluoroscopy guidance depends on spinal level. The previous studies using real time fluoroscopy demonstrated that the incidence of intravascular injection of cervical transforaminal epidural block is higher than that of lumbosacral transforaminal epidural block.

In this study, therefore, the investigators investigate the incidence of intravascular injection during cervical transforaminal epidural block using blunt needle, compared to the sharp needle.

Study Timeline

• Study Start: 2016-10-20
• Primary Completion: 2017-07-01
• Study Completion: 2017-07-25
• Status Verified: 2017-09
• Study First Submitted: 2017-09-14
• Study First Submitted QC: 2017-09-15
• Last Update Submitted: 2017-09-15
• Study First Posted: 2017-09-19
• Last Update Posted: 2017-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blunt-type block needle	block with Blunt-type block needle.	block with Blunt-type block needle.
Sharp-type block needle	block with sharp-type block needle.	block with Sharp-type block needle.

Primary Outcome Measures

Name	Time	Method
Intravascular injection	During procedure	Intravascular injection was defined as contrast media spreading out through the vascular channel during injection of contrast media under real time fluoroscopy. The investigators observed the intravascular injection during the procedure. The intravascular injection rate was calculated based on the total number of treated levels.

Secondary Outcome Measures

Name	Time	Method
Needling time	During procedure	Needling time for both the sharp and blunt needles was started upon insertion of the needle through the skin and ended upon injection of contrast media under real time fluoroscopy.