Spinal DiseasesNCT01020929
Incidence of Simultaneous Epidural and Intravascular Injection
An observational study of Spinal Diseases, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Diseases
- What is being tested?
- Blunt Coude, Quincke and Trucath
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Any patient undergoing a lumbar or cervical transforaminal epidural, as ordered by their treating physician.
- Ability to give informed consent.
Who cannot join
- Pregnancy
- Coagulopathy
- Systemic infection
- Allergy to contrast dye
- Mentally disabled or those whom are unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
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.
Read the detailed 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.
- 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).
- For each individual epidural site (each level and side per patient per setting counted as separate injections) the following will be identified:
- Patients age
- Diagnosis (reason for epidural) i.e. spinal stenosis, HNP, DDD
- Procedure level
- Gauge of needle
- Type of needle tip
- Aspiration of blood in needle hub pre-injection
- Contrast pattern using real time fluoroscopy
- Number of attempts of needle positioning
- Total fluoro time per case
- The physician will routinely wear a ring radiation badge to determine average radiation exposure to his hand.
- Analyze results
- Confirm incidence of intravascular pattern per level and determine incidence of mixed intravascular-epidural pattern per level.
- 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.
- Conditions
- Spinal Diseases
- Being tested
- Blunt Coude, Quincke, Trucath
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blunt CoudeDevice
Type of needle tip
QuinckeDevice
Type of needle tip
TrucathDevice
Type of needle tip
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or Absence of Vascular Patterns
Measured: At the time of injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DiseasesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew W Smuck, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020929
- Sponsor's protocol ID
- SU-09222009-3980
- Other IDs
- 16750
- Status last verified
- Jun 2012
- First submitted
- 5 Nov 2009
- Last updated
- 6 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Simultaneous Epidural and Intravascular Injection During Cervical and Lumbosacral Transforaminal Epidural Injections
- ClinicalTrials.gov ID
- NCT01020929
- Acronym / sponsor ID
- SU-09222009-3980
- Conditions
- Spinal Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 26 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
- 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).
- For each individual epidural site (each level and side per patient per setting counted as separate injections) the following will be identified:
- Patients age
- Diagnosis (reason for epidural) i.e. spinal stenosis, HNP, DDD
- Procedure level
- Gauge of needle
- Type of needle tip
- Aspiration of blood in needle hub pre-injection
- Contrast pattern using real time fluoroscopy
- Number of attempts of needle positioning
- Total fluoro time per case
- The physician will routinely wear a ring radiation badge to determine average radiation exposure to his hand.
- Analyze results
- Confirm incidence of intravascular pattern per level and determine incidence of mixed intravascular-epidural pattern per level.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Any patient undergoing a lumbar or cervical transforaminal epidural, as ordered by their treating physician.
- Ability to give informed consent.
Key exclusion criteria (5 listed)
- Pregnancy
- Coagulopathy
- Systemic infection
- Allergy to contrast dye
- Mentally disabled or those whom are unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blunt CoudeType of needle tip | Device | – |
| QuinckeType of needle tip | Device | – |
| TrucathType of needle tip | Device | – |
Primary outcome
Presence or Absence of Vascular Patterns
Time frame: At the time of injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew W Smuck principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Diseases, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or Absence of Vascular Patterns (time frame: At the time of injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2012.