Incidence of Simultaneous Epidural and Intravascular Injection

NCT01020929 | Completed

• 2 other identifiers: SU-09222009-398016750
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Diseases

Outcome Measures

Primary Outcomes (1)

• Presence or Absence of Vascular Patterns

  At the time of injection

Interventions

Blunt Coude DEVICE

Type of needle tip

Quincke DEVICE

Type of needle tip

Trucath DEVICE

Type of needle tip

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We plan to enroll a total of 500 subjects ( 250 subjects undergoing cervical and 250 subjects undergoing lumbosacral transforaminal epidural injection ) ;(iii) patients will have radiculopathies, herniated discs, and spinal stenosis coming to Stanford for an epidural steroid injection

You may qualify if:

• Any patient undergoing a lumbar or cervical transforaminal epidural, as ordered by their treating physician.
• Ability to give informed consent.

You may not qualify if:

• Pregnancy
• Coagulopathy
• Systemic infection
• Allergy to contrast dye
• Mentally disabled or those whom are unable to give informed consent

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Officials

• Matthew W Smuck

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2009
• First Posted: November 26, 2009
• Study Start: July 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 6, 2012

Record last verified: 2012-06

Locations

US (1)