Correlation of Intravascular Injection Rate and Severity of Cervical Neural Foraminal Stenosis

Not Applicable

• Conditions: Analgesia, Epidural
• Interventions: Procedure: Cervical transforaminal epidural steroid injection

• Registration Number: NCT04071483
• Lead Sponsor: Kyungpook National University Hospital

Brief Summary

This study evaluates whether there is a correlation between intravascular injection rate and severity of cervical foraminal stenosis during cervical transforaminal epidural steroid injection

Detailed Description

Cervical transforaminal epidural steroid injection (CTFESI) is useful option to improve cervical radicular pain. However, severe complication can occur by CTFESI such as epidural hematomas, infection, inadvertent intramedullary cord injections, and embolic infarct when inadvertent intra-arterial injection of particulate steroids has occurred.

The incidence of intravascular injection during CTFESI was known as 20.6% \~ 32.8% and it is higher than other level of spinal transforaminal epidural injection.

To avoid complication due to intravascular injection during CTFESI, risk factors was should be evaluated. However, there was no study about risk factors of intravascular injection during CTFESI. The investigators could assume the severity of cervical neural foraminal spinal stenosis could affect the incidence of intravascular injection, pain intensity and effectiveness during CTFESI.

Thus, the investigators designed this study to investigate whether there is a correlation between intravascular injection rate and severity of cervical foraminal stenosis during CTFESI.

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2019-08-26
• Study First Submitted QC: 2019-08-26
• Study First Posted: 2019-08-28
• Primary Completion: 2019-08-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-05
• Last Update Posted: 2019-09-09
• Study Completion: 2019-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate stenosis	Cervical transforaminal epidural steroid injection	Moderate cervical neural foraminal stenosis is narrowest width of the neural foramen was \>50% of the width of the width of the extraforaminal nerve root at the level of the anterior margin of the superior articular process.
Severe stenosis	Cervical transforaminal epidural steroid injection	Severe cervical neural foraminal stenosis is narrowest width of the neural foramen was ≤50% of the extraforaminal nerve root width

Primary Outcome Measures

Name	Time	Method
Intravascular injection	During procedure	Intravascular injection is defined as contrast media spreading out through the vascular channel during injection of contrast media under real time fluoroscopy

Secondary Outcome Measures

Name	Time	Method
Pain intensity	Before treatment and at 1 month after treatment	Pain intensity will be evaluated using a numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable).

Trial Locations

Locations (1)

Kyungpook national university hospital; 🇰🇷 Daegu, Korea, Republic of