Safety Study of Different Needle Types During Epidural Injections.
| Status: | Archived |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | July 2009 |
| End Date: | June 2011 |
"Influence of Needle Type on the Incidence of Intravascular Injection During Transforaminal Epidural Injections"
Interventional spine procedures are becoming more common. Safety is partly related to proper
technique. Injection of steroids and local anesthetics in the vascular space may have
serious complications. In addition to safety concerns, if the medication is not delivered
to the desired location (epidural space) the injection may not be effective. The purpose of
this study is to determine if the incidence of intravascular injection differs between
different needle types used during transforaminal epidural injections.
The investigators plan to enroll a total of 500 subjects ( 250 subjects undergoing cervical
and 250 subjects undergoing lumbosacral transforaminal epidural injection ) ; patients will
have radiculopathies, herniated discs, degenerative discs, and spinal stenosis coming to
Stanford for an epidural steroid injection.
To date, no study has reported the comparative incidence of intravascular injection during
transforaminal epidural injections with other needle types.
Any patient scheduled by their treating physiatrist or spine surgeon for a transforaminal
epidural injection 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 subject randomization.
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 will perform fluoroscopically-guided transforaminal epidural
injections. (standard of care)
2. Different types of needle tips will be used en block to allow comparisons between
groups of patients who received injections with different needle types.
3. For each injection the final location of the needle tip will be recorded and the
dynamic flow of contrast will be observed under live fluoroscopy. The presence or
absence of vascular patterns will be recorded. The observed pattern will be recorded as
one of the following categories: epidural only, vascular only, or simultaneous epidural
and vascular.
4. If a soft tissue injection is initially observe, the needle will be repositioned until
one of the above contrast patterns is seen. When a vascular contrast pattern is
observe, the needle will be repositioned. Once an epidural pattern is observe alone,
the treatment solution will be injected.
5. Analyze data.
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.
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