Incidence of Simultaneous Epidural and Intravascular Injection

Spinal Diseases Clinical Trial

Official title:

Incidence of Simultaneous Epidural and Intravascular Injection During Cervical and Lumbosacral Transforaminal Epidural Injections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01020929
• Other study ID #: SU-09222009-3980
• Secondary ID: 16750
• Status: Completed
• Phase: N/A
• First received: November 5, 2009
• Last updated: June 5, 2012
• Start date: July 2009
• Est. completion date: September 2011

Study information

• Verified date: June 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion:

1. Any patient undergoing a lumbar or cervical transforaminal epidural, as ordered by their treating physician.

2. Ability to give informed consent.

Exclusion:

1. Pregnancy

2. Coagulopathy

3. Systemic infection

4. Allergy to contrast dye

5. Mentally disabled or those whom are unable to give informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Spinal Diseases

Intervention

Device:
• Blunt Coude
Type of needle tip
• Quincke
Type of needle tip
• Trucath
Type of needle tip

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or Absence of Vascular Patterns		At the time of injection	Yes