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TerminatedNCT03057197Updated Mar 18, 2019

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

An interventional study of new caudal injection technique in Lumbosacral Radicular Pain, sponsored by Yonsei University. Terminated at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-03-18.

Sponsored by Yonsei University · Not applicable, Interventional, and Other

Why this study was terminated
The results of the interim analysis showed significant results.
Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Lumbosacral Radicular Pain
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In context

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
130 participants (actual)

Study arms

  • 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

Interventions

  • Procedurenew 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

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What researchers measure

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.

    Time frame: 5 seconds after injection of contrast media via block needle.

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Study locations

1 site
  • Yonsei University College of Medicine, Department of internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center
    Seoul, Korea, Republic of
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03057197
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Feb 17, 2017
Start date
Mar 2, 2017
Primary completion
Apr 23, 2018
Completion
Apr 23, 2018
Last update
Mar 18, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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