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Clinical Trials/NCT03057197
NCT03057197
Terminated
Not Applicable

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

Yonsei University1 site in 1 country130 target enrollmentMarch 2, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lumbosacral Radicular Pain
Sponsor
Yonsei University
Enrollment
130
Locations
1
Primary Endpoint
the incidence of intravascular injection
Status
Terminated
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 2, 2017
End Date
April 23, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult patients (20-80 years of age) who were scheduled to receive caudal epidural injection for lumbosacral radicular pain at our 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

Outcomes

Primary Outcomes

the incidence of intravascular injection

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

the incidence of intravascular injection in the conventional method group and the new method group during the caudal epidural injections.

Study Sites (1)

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