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

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.

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Key information

Conditions

Lumbosacral Radicular Pain

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

pregnancy
coagulopathy
systemic infection
any active infection at the injection site
history of allergy to contrast media, local anesthetics, corticosteroid
patients unable to communicate or patients with cognitive dysfunction

Treatment and study plan

S1 transforaminal epidural steroid(dexamethasone) injection

Drug

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

Primary outcomes

the incidence of intravascular injection in the medial approach group in S1 foramen

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

Time frame: 5 seconds after injection of contrast media via block needle.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Aug 15, 2016
Registry last updated: May 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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