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Incidence of Simultaneous Epidural and Intravascular Injection

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clinicaltrials.gov/study/NCT01020929
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT010209290
Trial Recruitment Size
2000
Trial Sponsor
Stanford University
Stanford University
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Clinical Trial Start Date
2009
0
Primary Completion Date
2011
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Study Completion Date
2011
0
Clinical Trial Study Type
Observational0
Observational Clinical Trial Type
Cohort0
Observational Study Perspective
Prospective0
Participating Facility
Stanford University School of Medicine
Stanford University School of Medicine
0
Official Name
Incidence of Simultaneous Epidural and Intravascular Injection During Cervical and Lumbosacral Transforaminal Epidural Injections0
Last Updated
June 6, 2012
0
Study summary

The investigator hopes to learn the incidence of needle placement in both the epidural and intravascular space, and learn mixed epidural-intravascular pattern related to needle type, gauge, and level of injection. We also hope to evaluate the length of fluoroscopy time when using real time fluoroscopy during contrast dye injection, evaluate the radiation exposure to the hands of the physician during this protocol, and confirm the incidence fo intravascular injection and sensitivity of needle flash of blood, In the lumbar spine, vascular contrast patterns are more than twice as likely to appear simultaneous to the anticipated epidural pattern, than they are to occur alone. This is important since practitioners are more likely to miss a vascular pattern that occurs simultaneous to epidural spread, than they are to occur alone. The incidence of intravascular penetration in cervical transforaminal epidural injections is known to exceed that of lumbar injections, however no study has determined the incidence of simultaneous epidural and vascular injection in the cervical spine. This study may prove that real time fluoroscopy during contrast injection is warranted to prevent intravascular injection and resultant side effects to support this as standard of care. Intermittent fluoroscopy can yield false-negative results for intravascular injection when simultaneous epidural and intravascular injection occurs. This could lead to an increased risk of complication from intravascular injection of medications and reduce overall efficacy. No studies to date have quantified the incidence of needle placement located in both the intravascular space and epidural space simultaneously.

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