Vascular ComplicationsNCT05031936
: Intravascular Injection Rates During Cervical Medial Branch Block
A study testing cervical spinal injection with 0.2% ropivacaine in people with Vascular Complications, 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 intravascular injection rates during cervical medial branch block. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Vascular Complications
- What is being tested?
- cervical spinal injection with 0.2% ropivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Aug 2021to 30 Oct 2022
- 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 intravascular injection rates during cervical medial branch block.
Read the detailed description
In previous reports, the use of Toughy needle was thought to reduce the incidence of intravascular injection as low as 2.9% 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, we 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, we 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 cervical medial branch block
- Conditions
- Vascular Complications
- Being tested
- cervical spinal injection with 0.2% ropivacaine
- Keywords
- intravascular injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical spinal injection with 0.2% ropivacaineProcedure or surgery
spinal injections performed in cervical pillar area to relieve chronic neck pain
| Study group | Role | What they receive |
|---|---|---|
| Touhy needle group | Active comparator | cervical medial branch block using touhy needle Receives: Procedure: cervical spinal injection with 0.2% ropivacaine |
| Quincke needle group | Placebo comparator | cervical medial branch block using quincke needle Receives: Procedure: cervical spinal injection with 0.2% ropivacaine |
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 cervical medial branch block
Measured: 1 minute after finishing cervical medial branch block
Secondary outcomes (2)
time required to complete cervical medial branch block
time required to complete cervical medial branch block
Measured: Baseline, 1 second after the completion of cervical medial branch block
radiation amout to complete cervical medial branch block
radiation amout to complete cervical medial branch block
Measured: Baseline, 1 second after the completion of cervical 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 posted2 Sep 2021
- Study start12 Aug 2021
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular ComplicationsStudies 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
- 67 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, Principal investigator, Keimyung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031936
- Sponsor's protocol ID
- 2021-07-014
- Status last verified
- Dec 2022
- First submitted
- 19 Aug 2021
- Last updated
- 20 Dec 2022
- Results posted
- 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 Injection Rates During Cervical and Lumbar Medial Branch Block Using Touhy or Quincke Type Needle
- ClinicalTrials.gov ID
- NCT05031936
- Acronym / sponsor ID
- 2021-07-014
- Conditions
- Vascular Complications
- Keywords
- intravascular injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 2 Sep 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 intravascular injection rates during cervical medial branch block.
Detailed description
In previous reports, the use of Toughy needle was thought to reduce the incidence of intravascular injection as low as 2.9% 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, we 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, we 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 cervical 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: cervical spinal injection with 0.2% ropivacainecervical medial branch block using touhy needle |
| Quincke needle group | Placebo comparator | Procedure: cervical spinal injection with 0.2% ropivacainecervical medial branch block using 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 |
|---|---|---|
| cervical spinal injection with 0.2% ropivacainespinal injections performed in cervical pillar area to relieve chronic neck pain | Procedure or surgery | Quincke needle group, Touhy needle group |
Primary outcome
incidence of intravascular injection
Time frame: 1 minute after finishing cervical medial branch block
incidence of intravascular injection during cervical medial branch block
2 secondary outcomes
time required to complete cervical medial branch block
Time frame: Baseline, 1 second after the completion of cervical medial branch block
radiation amout to complete cervical medial branch block
Time frame: Baseline, 1 second after the completion of cervical 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 20 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Vascular Complications
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
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 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 cervical spinal injection with 0.2% ropivacaine in people with Vascular Complications, 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 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. 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 cervical 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 20 Dec 2022.