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

NCT03057197 | Terminated

• 1 other identifier: 4-2016-1030
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbosacral Radicular Pain

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Group A

NO INTERVENTION

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

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

Procedure: new caudal injection technique

Interventions

new caudal injection technique PROCEDURE

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

Group B

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University College of Medicine, Department of internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 17, 2017
• Study Start: March 2, 2017
• Primary Completion: April 23, 2018
• Study Completion: April 23, 2018
• Last Updated: March 18, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)