ClinicalTrials.gg
RecruitingNCT04467398Updated Aug 4, 2023

Incidence of Intravascular (IV) Injection During Trigeminal Nerve Blocks

An observational study in Trigeminal Neuralgia, Facial Pain and Postherpetic Neuralgia, sponsored by Seoul National University. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-08-04.

Sponsored by Seoul National University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Started Jul 2020; still recruiting 6 years 3 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Ages
19 Years to 85 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Trigeminal Neuralgia
  • Facial Pain
  • Postherpetic Neuralgia
  • Cluster Headache
03

In context

Trigeminal Neuralgia

140 studies on the registry are indexed under Trigeminal Neuralgia; 44 are open to participants now.

This study's planned enrollment of 200 is above the median of 84 across 38 observational studies indexed under Trigeminal Neuralgia.

Browse Trigeminal Neuralgia studies →

Lead sponsor

Seoul National University is the lead sponsor of 32 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The patients who scheduled to undergo trigeminal nerve block due to the facial pain

Exclusion criteria

Exclusion Criteria:

  • Refusal of the patient
  • Pregnancy
  • Coagulopathy
  • Local or systemic infection
  • Allergy to injectate
  • Anatomical deformation of the skull
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Tuohy needle group

    The participants who undergo the trigeminal nerve block using 22 guage Tuohy needle.

    Procedure: trigeminal nerve block

  • Quincke needle group

    The participants who undergo the trigeminal nerve block using 22 guage Quincke needle.

    Procedure: trigeminal nerve block

Interventions

  • Proceduretrigeminal nerve block

    Trigeminal nerve or branch block using 22 gauge Quincke or Tuohy needle under fluoroscopic guidance.

06

What researchers measure

Primary outcomes

  1. IV uptake prevalence (%)

    The incidence of intravascular injection during the procedure by digital subtraction angiography(DSA).

    Time frame: During the procedure

Secondary outcomes

  1. Difference in incidence of intravascular injection

    Difference in incidence of intravascular injection according to needle type by DSA.

    Time frame: During the procedure

  2. Total incidence of blood aspiration

    Total incidence of blood aspiration by regurgitation.

    Time frame: During the procedure

  3. Total incidence of intravascular injection

    Total incidence of intravascular injection under non-DSA technique.

    Time frame: During the procedure

  4. 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.

    Time frame: During the procedure

  5. The number of needle adjustment.

    The number of needle adjustment due to the intravascular uptake.

    Time frame: During the procedure

  6. Total volume of local anesthetics for skin anesthesia.

    Total volume of local anesthetics for skin anesthesia.

    Time frame: During the procedure

  7. Time for the procedure.

    Time for the procedure.

    Time frame: During the procedure

  8. Total amount of radiation exposure for the procedure.

    Total amount of radiation exposure for the procedure.

    Time frame: During the procedure

  9. Laterality

    The difference in incidence by the lateriality.

    Time frame: During the procedure

  10. Final pattern of the fluoroscopic image

    The quality of the image(3: excellent, 2: acceptable, 1: not relevant)

    Time frame: During the procedure

  11. Post-procedure pain

    NRS pain score after the procedure in recovery room

    Time frame: Within 1 hour after the procedure.

  12. 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)

    Time frame: Within 1 hour after the procedure.

  13. The difference in incidence of blood aspiration

    Difference in incidence of intravascular injection according to needle type by regurgitation.

    Time frame: During the procedure.

  14. The difference in incidence of intravascular injection.

    Difference in incidence of intravascular injection according to needle type by non-DSA technique.

    Time frame: During the procedure

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04467398
Lead sponsor
Seoul National University
Responsible party
Jeeyoun Moon (Associate Professor, Seoul National University) — Principal investigator
First posted
Jul 13, 2020
Start date
Jul 20, 2020
Primary completion
Jun 15, 2024 (estimated)
Completion
Jun 15, 2024 (estimated)
Last update
Aug 4, 2023

Study contacts

Jee Youn Moon, MD, PhD
Contact
jymoon0901@gmail.com
82220722952
Yongjae Yoo, MD, PhD
Contact
rkdarkef@gmail.com
82220722952

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion