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

Lumbosacral Radicular Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03057197
• Other study ID #: 4-2016-1030
• Status: Terminated
• Phase: N/A
• Start date: March 2, 2017
• Est. completion date: April 23, 2018

Study information

• Verified date: March 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 130
• Est. completion date: April 23, 2018
• Est. primary completion date: April 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbosacral Radicular Pain

Intervention

Procedure:
• new caudal injection technique
new caudal injection technique is applied to the Group B, which is that the needle only penetrates the sacrococcygeal ligament without being inserted into the sacral canal

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University College of Medicine, Department of internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of intravascular injection	the incidence of intravascular injection in the conventional method group and the new method group during the caudal epidural injections.	5 seconds after injection of contrast media via block needle.