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

Not Applicable

Terminated

• Conditions: Lumbosacral Radicular Pain
• Interventions: Procedure: new caudal injection technique

• Registration Number: NCT03057197
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-16
• Study First Posted: 2017-02-17
• Study Start: 2017-03-02
• Primary Completion: 2018-04-23
• Study Completion: 2018-04-23
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 130

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	new caudal injection technique	New method group (n=85): same as conventional method group except caudal injection right after penetrating the sacrococcygeal ligament.

Primary Outcome Measures

Name	Time	Method
the incidence of intravascular injection	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.

Trial Locations

Locations (1)

Yonsei University College of Medicine, Department of internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center; 🇰🇷 Seoul, Korea, Republic of