Intravascular InjectionNCT05020509
Intravascular Injection Rates During Lumbar Medial Branch Block
A study testing medial branch block in people with Intravascular Injection, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to compare using Toughy needle has an advantage of reducing the incidence of vasucular puncture during lumbar medial branch block. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Intravascular Injection
- What is being tested?
- medial branch block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Aug 2021to 30 Oct 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- facet joint arthropathy
Who cannot join
- allergy to local anesthetics or contrast medium
- pregnancy
- spine deformity
- neurologic abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intravascular Injection Rates During Cervical and Lumbar Medial Branch Block Using Touhy or Quincke Type Needle
The purpose of this study is to compare using Toughy needle has an advantage of reducing the incidence of vasucular puncture during lumbar medial branch block.
Read the detailed description
In previous reports, the use of Toughy needle was thought to reduce the incidence of intravascular injection during lumbar transforaminal injection. Blunt needles with a pencil point tip, such as Whitacre needles, are not as sharp at their tip as are Quincke needles, which have bevels. Toughy or blunt needles may therefore be less likely to penetrate a vessel during a procedure. Hence, the investigators postulated the incidence of intravenous uptake would be significantly lower using a Toughy needle than using a Quincke needle for lumbar medial branch block. To confirm the intravascular injection rates, the investigators used the real time fluoroscopy after injection of contrast medium.
The goal of this study was to compare the incidence of intravascular injection rate betweeen Toughy and Quincke needles using real time fluoroscopy during lumbar medial branch block
- Conditions
- Intravascular Injection
- Being tested
- medial branch block
- Keywords
- intravascular injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medial branch blockProcedure or surgery
Also called lumbar medial branch block
lumbar medial branch block
| Study group | Role | What they receive |
|---|---|---|
| Touhy needle group | Active comparator | medial branch block with touhy needle Receives: Procedure: medial branch block |
| Quincke needle group | Placebo comparator | medial branch block with Quincke needle Receives: Procedure: medial branch block |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of intravascular injection
incidence of intravascular injection during lumbar medial branch block
Measured: 1 minute after finishing lumbar medial branch block
Secondary outcomes (2)
time required to complete lumbar medial branch block
time required to complete lumbar medial branch block
Measured: Baseline, 1 second after the completion of lumbar medial branch block
radiation amout to complete lumbar medial branch block
radiation amout to complete lumbar medial branch block
Measured: Baseline, 1 second after the completion of lumbar medial branch block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start12 Aug 2021
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravascular InjectionStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020509
- Sponsor's protocol ID
- 2021-07-014-001
- Status last verified
- Aug 2021
- First submitted
- 19 Aug 2021
- Last updated
- 2 Nov 2021
- 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 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravascular Injection Rates During Cervical and Lumbar Medial Branch Block Using Touhy or Quincke Type Needle
- ClinicalTrials.gov ID
- NCT05020509
- Acronym / sponsor ID
- 2021-07-014-001
- Conditions
- Intravascular Injection
- Keywords
- intravascular injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 25 Aug 2021 (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.
The purpose of this study is to compare using Toughy needle has an advantage of reducing the incidence of vasucular puncture during lumbar medial branch block.
Detailed description
In previous reports, the use of Toughy needle was thought to reduce the incidence of intravascular injection during lumbar transforaminal injection. Blunt needles with a pencil point tip, such as Whitacre needles, are not as sharp at their tip as are Quincke needles, which have bevels. Toughy or blunt needles may therefore be less likely to penetrate a vessel during a procedure. Hence, the investigators postulated the incidence of intravenous uptake would be significantly lower using a Toughy needle than using a Quincke needle for lumbar medial branch block. To confirm the intravascular injection rates, the investigators used the real time fluoroscopy after injection of contrast medium.
The goal of this study was to compare the incidence of intravascular injection rate betweeen Toughy and Quincke needles using real time fluoroscopy during lumbar medial branch block
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Touhy needle group | Active comparator | Procedure: medial branch blockmedial branch block with touhy needle |
| Quincke needle group | Placebo comparator | Procedure: medial branch blockmedial branch block with Quincke needle |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- facet joint arthropathy
Key exclusion criteria (4 listed)
- allergy to local anesthetics or contrast medium
- pregnancy
- spine deformity
- neurologic abnormality
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 |
|---|---|---|
| medial branch blockAlso: lumbar medial branch blocklumbar medial branch block | Procedure or surgery | Quincke needle group, Touhy needle group |
Primary outcome
incidence of intravascular injection
Time frame: 1 minute after finishing lumbar medial branch block
incidence of intravascular injection during lumbar medial branch block
2 secondary outcomes
time required to complete lumbar medial branch block
Time frame: Baseline, 1 second after the completion of lumbar medial branch block
radiation amout to complete lumbar medial branch block
Time frame: Baseline, 1 second after the completion of lumbar medial branch block
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 2 Nov 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medial branch block in people with Intravascular Injection, 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 1 inclusion and 4 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 2 Nov 2021. 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. Some participants in this study may receive a placebo. 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?
incidence of intravascular injection (time frame: 1 minute after finishing lumbar medial branch block). 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 2 Nov 2021.