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Safety Study of Different Needle Types During Epidural Injections.

2014-08-27 03:17:43 | BioPortfolio

Summary

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.

Description

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Spinal Diseases

Intervention

Blunt Coude, Quinke, Chiba, Touhy, Pencil

Location

Stanford University School of Medicine
Stanford
California
United States
94305

Status

Not yet recruiting

Source

Stanford University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:43-0400

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Reduced blood flow to the spinal cord which is supplied by the anterior spinal artery and the paired posterior spinal arteries. This condition may be associated with ARTERIOSCLEROSIS, trauma, emboli, diseases of the aorta, and other disorders. Prolonged ischemia may lead to INFARCTION of spinal cord tissue.

Inflammation of the spinal cord. Relatively common etiologies include infections; AUTOIMMUNE DISEASES; SPINAL CORD; and ischemia (see also SPINAL CORD VASCULAR DISEASES). Clinical features generally include weakness, sensory loss, localized pain, incontinence, and other signs of autonomic dysfunction.

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Pathological processes involving any of the BLOOD VESSELS feeding the SPINAL CORD, such as the anterior and paired posterior spinal arteries or their many branches. Disease processes may include ATHEROSCLEROSIS; EMBOLISM; and ARTERIOVENOUS MALFORMATIONS leading to ISCHEMIA or HEMORRHAGE into the spinal cord (hematomyelia).

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