The Influence of Needle-insertion Depth on Successful Epidurogram and Clinical Outcome in Caudal Epidural Injections
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|ClinicalTrials.gov Identifier: NCT03057197|
Recruitment Status : Terminated (The results of the interim analysis showed significant results.)
First Posted : February 17, 2017
Last Update Posted : March 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lumbosacral Radicular Pain||Procedure: new caudal injection technique||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||The Influence of Needle-insertion Depth on Successful Epidurogram and Clinical Outcome in Caudal Epidural Injections: A Randomized Clinical Trial|
|Actual Study Start Date :||March 2, 2017|
|Actual Primary Completion Date :||April 23, 2018|
|Actual Study Completion Date :||April 23, 2018|
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
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057197
|Korea, Republic of|
|Yonsei University College of Medicine, Department of internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center|
|Seoul, Korea, Republic of|