NCT03057197

The Influence of Needle-insertion Depth on Successful Epidurogram and Clinical Outcome in Caudal Epidural Injections

Terminated NA Last updated 18 March 2019

What this trial tests

NA trial testing new caudal injection technique in Lumbosacral Radicular Pain in 130 participants. Terminated before completion.

Timeline

2 March 2017

Primary endpoint
23 April 2018

23 April 2018

Quick facts

Lead sponsor	Yonsei University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	130
Start date	2 March 2017
Primary completion	23 April 2018
Estimated completion	23 April 2018
Sites	1 location across South Korea

Drugs / interventions tested

• new caudal injection technique

Conditions studied

• Lumbosacral Radicular Pain — all drugs for Lumbosacral Radicular Pain →

Sponsor

Yonsei University

Who can join

Adults 20 to 80, any sex, with Lumbosacral Radicular Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Caudal epidural injections have been commonly performed in patients with low back pain and radiculopathy. Conventional caudal epidural injections, which the needle is advanced into the sacral canal, present a potential risk of penetration of the epidural venous plexus or dura. The investigators hypothesized that a new caudal injection technique, which the needle only penetrates the sacrococcygeal ligament without being inserted into the sacral canal, might represent a safe alternative, with a lower incidence of intravascular injections and patient's discomfort during the procedure than the conventional technique. The study is designed to investigate the influence of the depth of the inserted needle on successful epidurogram and clinical outcome in caudal epidural injections under the ultrasound and digital subtraction angiography.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.