Spinal Diseases Clinical Trial
Official title:
Incidence of Simultaneous Epidural and Intravascular Injection During Cervical and Lumbosacral Transforaminal Epidural Injections
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.
Any patient undergoing a lumbar or cervical transforaminal epidural, as ordered by their
treating physician will provide written informed consent before the procedure is conducted.
The contents of the consent forms will be used to explain the study to patients. There are
no drug treatments associated with the study other than those which are part of the existing
treatment plan. There is no subject randomization. Subjects will be recruited consecutively.
Patients with pregnancy, coagulopathy, systemic infection, allergy to contrast dye, mentally
disabled or those whom are unable to give informed consent will be excluded from the study.
1. One experienced physician (>5 years experience) will use intermittent fluoroscopy to
place needle for transforaminal epidural position using standard techniques. The
physician will then use real time fluoroscopy when injecting the contrast solution to
determine pattern of contrast flow (his standard of care).
2. For each individual epidural site (each level and side per patient per setting counted
as separate injections) the following will be identified:
1. Patients age
2. Diagnosis (reason for epidural) i.e. spinal stenosis, HNP, DDD
3. Procedure level
4. Gauge of needle
5. Type of needle tip
6. Aspiration of blood in needle hub pre-injection
7. Contrast pattern using real time fluoroscopy
8. Number of attempts of needle positioning
9. Total fluoro time per case
3. The physician will routinely wear a ring radiation badge to determine average radiation
exposure to his hand.
4. Analyze results
5. Confirm incidence of intravascular pattern per level and determine incidence of mixed
intravascular-epidural pattern per level.
6. Quantify average fluoro exposure time and compare to average flouro time of identical
procedures using intermittent fluoroscopy.
All of the procedures for this protocol are standard of care.
All data is collected during the procedure. There will be no follow-ups after the procedure.
We will be asking participants if they are willing to be contacted regarding future research
studies that may be of interest to them.
;
Observational Model: Cohort, Time Perspective: Prospective
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