Trigeminal NeuralgiaNCT04467398
Incidence of Intravascular (IV) Injection During Trigeminal Nerve Blocks
An observational study of Trigeminal Neuralgia and Facial Pain, run by Seoul National University at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the incidence of intravascular injection during trigeminal nerve blocks. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Trigeminal Neuralgia, Facial Pain, Postherpetic Neuralgia
- What is being tested?
- trigeminal nerve block
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jul 2020to 15 Jun 2024
- How long will I take part?
- 1 Day
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients who scheduled to undergo trigeminal nerve block because of: 1. Trigeminal neuralgia/neuropathy 2. Postherpetic trigeminal neuralgia 3. Atypical facial pain 4. Cluster headache
Who may be able to join
- The patients who scheduled to undergo trigeminal nerve block due to the facial pain
Who cannot join
- Refusal of the patient
- Pregnancy
- Coagulopathy
- Local or systemic infection
- Allergy to injectate
- Anatomical deformation of the skull
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Jee Youn Moon, M.D., 82-10-5299-2036, jymoon0901@gmail.com
Jee Youn Moon, M.D.
About this study
Official title: Incidence of Intravascular (IV) Injection During Trigeminal Nerve Blocks and Impact of Needle Types to the IV Uptake: A Prospective Cohort Study
The purpose of this study is to investigate the incidence of intravascular injection during trigeminal nerve blocks.
Read the detailed description
The patients who already scheduled for trigeminal nerve blocks will be randomized in a 1:1 ratio to tuohy needle group or quincke needle group after being informed about the study.
- Being tested
- trigeminal nerve block
- Medical subject headings
- Trigeminal Neuralgia, Facial Pain, Neuralgia, Postherpetic, Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trigeminal nerve blockProcedure or surgery
Trigeminal nerve or branch block using 22 gauge Quincke or Tuohy needle under fluoroscopic guidance.
| Study group | Role | What they receive |
|---|---|---|
| Tuohy needle group | The participants who undergo the trigeminal nerve block using 22 guage Tuohy needle. Receives: Procedure: trigeminal nerve block | |
| Quincke needle group | The participants who undergo the trigeminal nerve block using 22 guage Quincke needle. Receives: Procedure: trigeminal nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
IV uptake prevalence (%)
The incidence of intravascular injection during the procedure by digital subtraction angiography(DSA).
Measured: During the procedure
Secondary outcomes (14)
Difference in incidence of intravascular injection
Difference in incidence of intravascular injection according to needle type by DSA.
Measured: During the procedure
Total incidence of blood aspiration
Total incidence of blood aspiration by regurgitation.
Measured: During the procedure
Total incidence of intravascular injection
Total incidence of intravascular injection under non-DSA technique.
Measured: During the procedure
The depth of inserted needle when the practitioner check the intravascular uptake under DSA technique.
The depth of inserted needle when the practitioner check the intravascular uptake under SDA technique.
Measured: During the procedure
The number of needle adjustment.
The number of needle adjustment due to the intravascular uptake.
Measured: During the procedure
Total volume of local anesthetics for skin anesthesia.
Total volume of local anesthetics for skin anesthesia.
Measured: During the procedure
Time for the procedure.
Time for the procedure.
Measured: During the procedure
Total amount of radiation exposure for the procedure.
Total amount of radiation exposure for the procedure.
Measured: During the procedure
Laterality
The difference in incidence by the lateriality.
Measured: During the procedure
Final pattern of the fluoroscopic image
The quality of the image(3: excellent, 2: acceptable, 1: not relevant)
Measured: During the procedure
Post-procedure pain
NRS pain score after the procedure in recovery room
Measured: Within 1 hour after the procedure.
The difficulty of the procedure
The difficulty grade by the practitioner(5:very easy, 4: relatively easy, 3:so so, 4:somewhat difficult, 1:very difficult)
Measured: Within 1 hour after the procedure.
The difference in incidence of blood aspiration
Difference in incidence of intravascular injection according to needle type by regurgitation.
Measured: During the procedure.
The difference in incidence of intravascular injection.
Difference in incidence of intravascular injection according to needle type by non-DSA technique.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start20 Jul 2020
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Seoul National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyoun Moon, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467398
- Sponsor's protocol ID
- 2004-207-1120
- Status last verified
- Aug 2023
- First submitted
- 22 May 2020
- Last updated
- 4 Aug 2023
- 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 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Intravascular (IV) Injection During Trigeminal Nerve Blocks and Impact of Needle Types to the IV Uptake: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04467398
- Acronym / sponsor ID
- 2004-207-1120
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Seoul National UniversityUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 13 Jul 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.
The purpose of this study is to investigate the incidence of intravascular injection during trigeminal nerve blocks.
Detailed description
The patients who already scheduled for trigeminal nerve blocks will be randomized in a 1:1 ratio to tuohy needle group or quincke needle group after being informed about the study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tuohy needle group | – | Procedure: trigeminal nerve blockThe participants who undergo the trigeminal nerve block using 22 guage Tuohy needle. |
| Quincke needle group | – | Procedure: trigeminal nerve blockThe participants who undergo the trigeminal nerve block using 22 guage Quincke needle. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who scheduled to undergo trigeminal nerve block because of: 1. Trigeminal neuralgia/neuropathy 2. Postherpetic trigeminal neuralgia 3. Atypical facial pain 4. Cluster headache
Key inclusion criteria (1 listed)
- The patients who scheduled to undergo trigeminal nerve block due to the facial pain
Key exclusion criteria (6 listed)
- Refusal of the patient
- Pregnancy
- Coagulopathy
- Local or systemic infection
- Allergy to injectate
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 |
|---|---|---|
| trigeminal nerve blockTrigeminal nerve or branch block using 22 gauge Quincke or Tuohy needle under fluoroscopic guidance. | Procedure or surgery | Quincke needle group, Tuohy needle group |
Primary outcome
IV uptake prevalence (%)
Time frame: During the procedure
The incidence of intravascular injection during the procedure by digital subtraction angiography(DSA).
14 secondary outcomes
Difference in incidence of intravascular injection
Time frame: During the procedure
Total incidence of blood aspiration
Time frame: During the procedure
Total incidence of intravascular injection
Time frame: During the procedure
The depth of inserted needle when the practitioner check the intravascular uptake under DSA technique.
Time frame: During the procedure
The number of needle adjustment.
Time frame: During the procedure
Total volume of local anesthetics for skin anesthesia.
Time frame: During the procedure
Time for the procedure.
Time frame: During the procedure
Total amount of radiation exposure for the procedure.
Time frame: During the procedure
Laterality
Time frame: During the procedure
Final pattern of the fluoroscopic image
Time frame: During the procedure
Post-procedure pain
Time frame: Within 1 hour after the procedure.
The difficulty of the procedure
Time frame: Within 1 hour after the procedure.
The difference in incidence of blood aspiration
Time frame: During the procedure.
The difference in incidence of intravascular injection.
Time frame: During the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- 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.
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 Trigeminal Neuralgia and Facial Pain, run by Seoul National University 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 6 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: status not confirmed, as of the sponsor's last update on 4 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jee Youn Moon, MD, PhD (82220722952, jymoon0901@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IV uptake prevalence (%) (time frame: During the procedure). 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 4 Aug 2023.