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The results of the interim analysis showed significant results.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University College of Medicine, Department of internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center | Seoul | South Korea |
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