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

Analgesia, Epidural Clinical Trial

Official title:

Correlation of Intravascular Injection Rate and Severity of Cervical Neural Foraminal Stenosis During Cervical Transforaminal Epidural Steroid Injection: a Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04071483
• Other study ID #: 2018-06-009-001
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: September 2019
• Source: Kyungpook National University Hospital
• Contact: Jimin Heo
• Phone: +82-53-420-5430
• Email: knuhmrc[@]knu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: September 30, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia, Epidural
• Constriction, Pathologic

Intervention

Procedure:
• Cervical transforaminal epidural steroid injection
Cervical transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of cervical radicular pain.

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook national university hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intravascular injection	Intravascular injection is defined as contrast media spreading out through the vascular channel during injection of contrast media under real time fluoroscopy	During procedure
Secondary	Pain intensity	Pain intensity will be evaluated using a numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable).	Before treatment and at 1 month after treatment