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

Kyungpook National University

Status: Unknown

Conditions: Analgesia, Epidural

Treatments: Procedure: Cervical transforaminal epidural steroid injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04071483

2018-06-009-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 2 patient groups

Moderate stenosis

Experimental group

Description:

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.

Treatment:

Procedure: Cervical transforaminal epidural steroid injection

Severe stenosis

Active Comparator group

Description:

Severe cervical neural foraminal stenosis is narrowest width of the neural foramen was ≤50% of the extraforaminal nerve root width

Treatment:

Procedure: Cervical transforaminal epidural steroid injection