The Incidence of the Intravascular Injection During S1 Transforaminal Epidural Steroid Injection in Two Approaches: Anteroposterior Versus Oblique
1 other identifier
interventional
201
1 country
1
Brief Summary
Lumbosacral transforaminal epidural steroid injection (TFESI) is helpful for the treatment of lumbosacral radicular pain, but in case of intravascular injection, infrequently serious complication can be developed. Against this backdrop, if there is any difference of frequency of intravascular injection incidence during S1 TFESI between method in anteroposterior view and method in oblique view using Scotty dog, the result can be crucial factor in selecting the approach. In addition, appropriate volume of injection will be checked in each approach.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 17, 2013
CompletedFirst Posted
Study publicly available on registry
August 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJuly 28, 2014
July 1, 2014
11 months
July 17, 2013
July 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the incidence of intravascular injection
the incidence of intravascular injection in the anteroposterior approach group and the oblique approach group
5 seconds after injection of contrast media via block needle.
Study Arms (2)
anteroposterior approach group
EXPERIMENTALanteroposterior approach group
oblique approach group
ACTIVE COMPARATORoblique approach group
Interventions
anteroposterior approach group (n=104): check intravascular injection while performing S1 transforaminal epidural steroid injection in anteroposterior view under fluoroscopy
oblique approach group (n=104): same as anteroposterior approach group except using oblique view
Eligibility Criteria
You may qualify if:
- Adult patients (20-80 years of age) who were scheduled to receive S1 transforaminal epidural steroid injection for lumbosacral radicular pain at our pain management clinic
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 120-752, South Korea
Related Publications (1)
Al-Shaikh B, George William M, Van Zundert AA. Using atmospheric pressure to inflate the cuff of the Portex Laryngeal Mask. Anaesthesia. 2005 Mar;60(3):296-7. doi: 10.1111/j.1365-2044.2005.04135.x. No abstract available.
PMID: 15710025BACKGROUND
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2013
First Posted
August 21, 2013
Study Start
July 1, 2013
Primary Completion
June 1, 2014
Study Completion
July 1, 2014
Last Updated
July 28, 2014
Record last verified: 2014-07