Inadvertent Arterial PunctureNCT04634955
S1 Transforaminal Injection and Vascular Incidence
A study testing tranforaminal epidural injection in people with Inadvertent Arterial Puncture, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
Intravascular incidence during S1 transforaminal injection is known to be higher than lumbar injection. Its incidence is reported to be 15~25%. This study was aimed to see if there is any benefit of reducing the intravasuclar injection rate when S1 transforaminal injection was performed by different fluorosopic… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Inadvertent Arterial Puncture
- What is being tested?
- tranforaminal epidural injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Nov 2020to 30 Apr 2021
- Phase
- Interventional
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- spinal stenosis
- herniated intervertebral disc
- failed back surgery syndrome
Who cannot join
- coagulopathy
- infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intravascular Incidence With Different Fluoroscopic Approach Method During S1 Trasnforaminal Injection
Intravascular incidence during S1 transforaminal injection is known to be higher than lumbar injection. Its incidence is reported to be 15~25%.
This study was aimed to see if there is any benefit of reducing the intravasuclar injection rate when S1 transforaminal injection was performed by different fluorosopic approach.
Read the detailed description
Fluorosocpically guided transforaminal epidural steroid injection is a popular interventional procedure that is effective in radicular pain conditions such as herniated interverebral disc, spinal stenosis and failed back surgery syndrome.
The incidence of inadvertent intravascular needle injection during lumbar transforaminal injection is reported as from 9.9% to 30.8%. In particular, S1 intravascular injection rate is more frequent than at the lumbar level.
Previous study reported that guiding the needle toward the S1 foramen using the S1 scotty dog image as a bony landmark, not in the classic way, but in an oblique fluoroscopic view, during L5 and S1 transforaminal epidural steroid injection, can save procedure time and reduce the risk of radiation exposure.
In this stidy, the investigators aimed to compare the incidence of intravascular injection rate by anteroposterior and oblique view approaches for S1 transforaminal epidural steroid injection. In addition, the investigators also compared the procedure time and radiation exposure between two approach method.
- Conditions
- Inadvertent Arterial Puncture
- Being tested
- tranforaminal epidural injection
- Keywords
- intravascular injection transforaminal injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tranforaminal epidural injectionProcedure or surgery
tranforaminal epidural injection which is performed by fluoroscopic guidance
| Study group | Role | What they receive |
|---|---|---|
| S1 transforaminal injection with oboique view | Active comparator | S1 transforaminal injection with oblique fluoroscopic view Receives: Procedure: tranforaminal epidural injection |
| S1 transforaminal injection with AP view | Active comparator | S1 transforaminal injection with anteroposterior fluoroscopic view Receives: Procedure: tranforaminal epidural injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
intravascular incidence
intravascular injection rate
Measured: 15 minutes after the completion of the intervention
Secondary outcomes (2)
procedure time
procedure time
Measured: 15 minutes after the completion of the intervention
radiation dose
radiation dose
Measured: 15 minutes after the completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start15 Nov 2020
- Primary completion15 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inadvertent Arterial PunctureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Hee Hong, Keimyung University Dongsan Medical Center
- Investigators
- Ji Hee Hong, PhD, Principal investigator, Keimyung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634955
- Sponsor's protocol ID
- 2020-08-028
- Status last verified
- Dec 2022
- First submitted
- 10 Nov 2020
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravascular Incidence With Different Fluoroscopic Approach Method During S1 Trasnforaminal Injection
- ClinicalTrials.gov ID
- NCT04634955
- Acronym / sponsor ID
- 2020-08-028
- Conditions
- Inadvertent Arterial Puncture
- Keywords
- intravascular injection transforaminal injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 18 Nov 2020 (actual)
- 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.
Intravascular incidence during S1 transforaminal injection is known to be higher than lumbar injection. Its incidence is reported to be 15~25%.
This study was aimed to see if there is any benefit of reducing the intravasuclar injection rate when S1 transforaminal injection was performed by different fluorosopic approach.
Detailed description
Fluorosocpically guided transforaminal epidural steroid injection is a popular interventional procedure that is effective in radicular pain conditions such as herniated interverebral disc, spinal stenosis and failed back surgery syndrome.
The incidence of inadvertent intravascular needle injection during lumbar transforaminal injection is reported as from 9.9% to 30.8%. In particular, S1 intravascular injection rate is more frequent than at the lumbar level.
Previous study reported that guiding the needle toward the S1 foramen using the S1 scotty dog image as a bony landmark, not in the classic way, but in an oblique fluoroscopic view, during L5 and S1 transforaminal epidural steroid injection, can save procedure time and reduce the risk of radiation exposure.
In this stidy, the investigators aimed to compare the incidence of intravascular injection rate by anteroposterior and oblique view approaches for S1 transforaminal epidural steroid injection. In addition, the investigators also compared the procedure time and radiation exposure between two approach method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S1 transforaminal injection with oboique view | Active comparator | Procedure: tranforaminal epidural injectionS1 transforaminal injection with oblique fluoroscopic view |
| S1 transforaminal injection with AP view | Active comparator | Procedure: tranforaminal epidural injectionS1 transforaminal injection with anteroposterior fluoroscopic view |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- spinal stenosis
- herniated intervertebral disc
- failed back surgery syndrome
Key exclusion criteria (2 listed)
- coagulopathy
- infection
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 |
|---|---|---|
| tranforaminal epidural injectiontranforaminal epidural injection which is performed by fluoroscopic guidance | Procedure or surgery | S1 transforaminal injection with AP view, S1 transforaminal injection with oboique view |
Primary outcome
intravascular incidence
Time frame: 15 minutes after the completion of the intervention
intravascular injection rate
2 secondary outcomes
procedure time
Time frame: 15 minutes after the completion of the intervention
radiation dose
Time frame: 15 minutes after the completion of the intervention
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 20 Dec 2022.
- Individual participant dataSharing planned: No
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.
Ji Hee Hong, PhD principal investigator
Keimyung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tranforaminal epidural injection in people with Inadvertent Arterial Puncture, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
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 3 inclusion and 2 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 20 Dec 2022. 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 South Korea. 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?
intravascular incidence (time frame: 15 minutes after the completion of the intervention). 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 20 Dec 2022.