The Influence of Needle-insertion Depth on Successful Epidurogram and Clinical Outcome in Caudal Epidural Injections: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Yonsei University
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- the incidence of intravascular injection
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- 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
- •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
Arms & Interventions
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.
Group B
New method group (n=85): same as conventional method group except caudal injection right after penetrating the sacrococcygeal ligament.
Intervention: new caudal injection technique (Procedure)
Outcomes
Primary Outcomes
the incidence of intravascular injection
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported