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Clinical Trials/NCT03286946
NCT03286946CompletedNot Applicable

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

Kyungpook National University Hospital0 sites108 target enrollmentStarted: October 20, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
108
Primary Endpoint
Intravascular injection

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Blunt-type block needle

Experimental

block with Blunt-type block needle.

Intervention: block with Blunt-type block needle. (Procedure)

Sharp-type block needle

Active Comparator

block with Sharp-type block needle.

Intervention: block with sharp-type block needle. (Procedure)

Outcomes

Primary Outcomes

Intravascular injection

Time Frame: 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 Outcomes

  • Needling time(During procedure)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Saeyoung Kim, MD, PhD

Associate professor

Kyungpook National University Hospital

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