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

Not Applicable

Completed

• Conditions: Lumbosacral Radicular Pain
• Interventions: Drug: S1 transforaminal epidural steroid(dexamethasone) injection

• Registration Number: NCT02867046
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-29
• Study First Submitted: 2016-08-07
• Study First Submitted QC: 2016-08-12
• Study First Posted: 2016-08-15
• Primary Completion: 2016-11-28
• Study Completion: 2016-11-28
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-17
• Last Update Posted: 2018-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
medial approach group	S1 transforaminal epidural steroid(dexamethasone) injection	-
lateral approach group	S1 transforaminal epidural steroid(dexamethasone) injection	-

Primary Outcome Measures

Name	Time	Method
the incidence of intravascular injection in the medial approach group in S1 foramen	5 seconds after injection of contrast media via block needle.
the incidence of intravascular injection in the lateral approach group in S1 foramen	5 seconds after injection of contrast media via block needle.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of