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CompletedNCT03286946Updated Sep 19, 2017

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

An interventional study of block with Blunt-type block needle. and block with sharp-type block needle. in Pain and Radicular; Neuropathic, Cervical, sponsored by Kyungpook National University Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-19.

Sponsored by Kyungpook National University Hospital · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pain
  • Radicular; Neuropathic, Cervical

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
108 participants (actual)

Study arms

  • Experimental
    Blunt-type block needle

    block with Blunt-type block needle.

    Procedure: block with Blunt-type block needle.

  • Active comparator
    Sharp-type block needle

    block with Sharp-type block needle.

    Procedure: block with sharp-type block needle.

Interventions

  • Procedureblock 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.

  • Procedureblock 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: During procedure

Secondary outcomes

  1. 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.

    Time frame: During procedure

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03286946
Lead sponsor
Kyungpook National University Hospital
Responsible party
Saeyoung Kim, MD, PhD (Associate professor, Kyungpook National University Hospital) — Principal investigator
First posted
Sep 19, 2017
Start date
Oct 20, 2016
Primary completion
Jul 1, 2017
Completion
Jul 25, 2017
Last update
Sep 19, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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