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

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

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.

Study Overview

• Status: Terminated
• Conditions: Lumbosacral Radicular Pain
• Intervention / Treatment: Procedure: new caudal injection technique

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Group A; 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.
Experimental: Group B; New method group (n=85): same as conventional method group except caudal injection right after penetrating the sacrococcygeal ligament.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2017
• Primary Completion (Actual): April 23, 2018
• Study Completion (Actual): April 23, 2018

Study Registration Dates

• First Submitted: February 15, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (Actual): February 17, 2017

Study Record Updates

• Last Update Posted (Actual): March 18, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 4-2016-1030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No