The Incidence of the Intravascular Injection During S1 Transforaminal Epidural Steroid Injection in Two Approaches: Medial vs Lateral in Anteroposterior View

Lumbosacral Radicular Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02867046
• Other study ID #: 4-2016-0442
• Status: Completed
• Phase: N/A
• Start date: July 29, 2016
• Est. completion date: November 28, 2016

Study information

• Verified date: May 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Lumbosacral transforaminal epidural steroid injection (TFESI) is helpful for the treatment of lumbosacral radicular pain, but in case of intravascular injection, infrequently serious complication can be developed. Against this backdrop, if there is any difference of frequency of intravascular injection incidence during S1 (sacrum 1) TFESI between method using medial approach and method using lateral approach in anteroposterior view, the result can be crucial factor in selecting the approach. In addition, appropriate volume of injection will be checked in each approach.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: November 28, 2016
• Est. primary completion date: November 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Adult patients (20-80 years of age) who were scheduled to receive S1 transforaminal epidural steroid injection for lumbosacral radicular pain at pain management clinic

Exclusion Criteria:

1. pregnancy

2. coagulopathy

3. systemic infection

4. any active infection at the injection site

5. history of allergy to contrast media, local anesthetics, corticosteroid

6. patients unable to communicate or patients with cognitive dysfunction

Related Conditions & MeSH terms

• Lumbosacral Radicular Pain

Intervention

Drug:
• S1 transforaminal epidural steroid(dexamethasone) injection
medial approach group (n=85): check intravascular injection while performing S1 transforaminal epidural steroid(dexamethasone) injection in medial side of S1 foramen under fluoroscopy lateral approach group (n=85): same as medial approach group except using lateral side of S1 foramen

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of intravascular injection in the medial approach group in S1 foramen		5 seconds after injection of contrast media via block needle.
Primary	the incidence of intravascular injection in the lateral approach group in S1 foramen		5 seconds after injection of contrast media via block needle.