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NCT01020929 · ClinicalTrials.gov registry record
Incidence of Simultaneous Epidural and Intravascular Injection
A clinical trial, sponsored by Stanford University.
- Completed
- Registry status
- 200
- Enrollment target
NCT01020929: Completed study, sponsored by Stanford University.
NCT01020929 is a clinical trial that has completed, run by Stanford University. The registered enrollment target is 200 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01020929 has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- 200 participants
- Enrollment target
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.
Interventions
- DEVICE Blunt Coude
- DEVICE Quincke
- DEVICE Trucath
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2009-07 |
| Est. Completion | 2011-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01020929
The ClinicalTrials.gov registry entry for NCT01020929 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Blunt Coude is the first listed.
NCT01020929 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01020929 about?
NCT01020929 is a clinical study titled "Incidence of Simultaneous Epidural and Intravascular Injection". 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 fluorosco...
What is the current status of trial NCT01020929?
This trial is currently completed. The enrollment target is 200 participants. The study started on 2009-07. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01020929?
The interventions under investigation include: Blunt Coude (DEVICE), Quincke (DEVICE), Trucath (DEVICE).
Who is sponsoring clinical trial NCT01020929?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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