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

NCT02867046 | Completed

• 1 other identifier: 4-2016-0442
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbosacral Radicular Pain

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

medial approach group

EXPERIMENTAL

Drug: S1 transforaminal epidural steroid(dexamethasone) injection

lateral approach group

ACTIVE COMPARATOR

Drug: S1 transforaminal epidural steroid(dexamethasone) injection

Interventions

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

lateral approach group; medial approach group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2016
• First Posted: August 15, 2016
• Study Start: July 29, 2016
• Primary Completion: November 28, 2016
• Study Completion: November 28, 2016
• Last Updated: May 18, 2018

Record last verified: 2018-05

Locations

KR (1)