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

Yonsei University

Status: Terminated

Conditions: Lumbosacral Radicular Pain

Treatments: Procedure: new caudal injection technique

Study type: Interventional

Funder types: Other

Identifiers

NCT03057197

4-2016-1030

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups

Group A

No Intervention group

Description:

Conventional method group (n=85): caudal injection after advancement of the needle into the sacral canal. Ultrasound is used to achieve accurate needle placement and we will check intravascular injection using digital subtraction angiography.

Group B

Experimental group

Description:

New method group (n=85): same as conventional method group except caudal injection right after penetrating the sacrococcygeal ligament.

Treatment:

Procedure: new caudal injection technique