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

Pain Clinical Trial

Official title:

The Difference of Intravascular Injection Rate During Cervical Transforaminal Epidural Block Using Blunt-type Block Needle Compared to Sharp-type Block Needle.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03286946
• Other study ID #: 2016-09-009
• Status: Completed
• Phase: N/A
• First received: September 14, 2017
• Last updated: September 15, 2017
• Start date: October 20, 2016
• Est. completion date: July 25, 2017

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: July 25, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Radicular; Neuropathic, Cervical
• Radiculopathy

Intervention

Procedure:
• block with Blunt-type block needle.
Under fluoroscopic guidance, cervical transforaminal epidural injections were performed using 22 gauge blunt needle. The needle position was confirmed using biplanar fluoroscopy and 2 ml of nonionic contrast media was injected to detect intravascular injection.
• block with sharp-type block needle.
Under fluoroscopic guidance, cervical transforaminal epidural injections were performed using 22 gauge sharp needle. The needle position was confirmed using biplanar fluoroscopy and 2 ml of nonionic contrast media was injected to detect intravascular injection.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intravascular injection	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.	During procedure
Secondary	Needling time	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.	During procedure