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

NCT03286946 | Completed

• 1 other identifier: 2016-09-009
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain; Radicular; Neuropathic, Cervical

Outcome Measures

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.

  During procedure

Secondary Outcomes (1)

• Needling time

  During procedure

Study Arms (2)

Blunt-type block needle

EXPERIMENTAL

block with Blunt-type block needle.

Procedure: block with Blunt-type block needle.

Sharp-type block needle

ACTIVE COMPARATOR

block with Sharp-type block needle.

Procedure: block with sharp-type block needle.

Interventions

block with Blunt-type block needle. PROCEDURE

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.

Blunt-type block needle

block with sharp-type block needle. PROCEDURE

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.

Sharp-type block needle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kyungpook National University Hospital: lead

MeSH Terms

Conditions

Pain

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 19, 2017
• Study Start: October 20, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 25, 2017
• Last Updated: September 19, 2017

Record last verified: 2017-09