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Incidence of Intravascular (IV) Injection During Trigeminal Nerve Blocks

Incidence of Intravascular (IV) Injection During Trigeminal Nerve Blocks and Impact of Needle Types to the IV Uptake: A Prospective Cohort Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04467398
Enrollment
200
Registered
2020-07-13
Start date
2020-07-20
Completion date
2024-06-15
Last updated
2023-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cluster Headache, Facial Pain, Postherpetic Neuralgia, Trigeminal Neuralgia

Brief summary

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.

Interventions

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

Sponsors

Seoul National University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
IV uptake prevalence (%)During the procedureThe incidence of intravascular injection during the procedure by digital subtraction angiography(DSA).

Secondary

MeasureTime frameDescription
Difference in incidence of intravascular injectionDuring the procedureDifference in incidence of intravascular injection according to needle type by DSA.
Total incidence of blood aspirationDuring the procedureTotal incidence of blood aspiration by regurgitation.
Total incidence of intravascular injectionDuring the procedureTotal incidence of intravascular injection under non-DSA technique.
The depth of inserted needle when the practitioner check the intravascular uptake under DSA technique.During the procedureThe depth of inserted needle when the practitioner check the intravascular uptake under SDA technique.
The number of needle adjustment.During the procedureThe number of needle adjustment due to the intravascular uptake.
Total volume of local anesthetics for skin anesthesia.During the procedureTotal volume of local anesthetics for skin anesthesia.
Post-procedure painWithin 1 hour after the procedure.NRS pain score after the procedure in recovery room
Total amount of radiation exposure for the procedure.During the procedureTotal amount of radiation exposure for the procedure.
LateralityDuring the procedureThe difference in incidence by the lateriality.
Final pattern of the fluoroscopic imageDuring the procedureThe quality of the image(3: excellent, 2: acceptable, 1: not relevant)
The difficulty of the procedureWithin 1 hour after the procedure.The difficulty grade by the practitioner(5:very easy, 4: relatively easy, 3:so so, 4:somewhat difficult, 1:very difficult)
The difference in incidence of blood aspirationDuring the procedure.Difference in incidence of intravascular injection according to needle type by regurgitation.
The difference in incidence of intravascular injection.During the procedureDifference in incidence of intravascular injection according to needle type by non-DSA technique.
Time for the procedure.During the procedureTime for the procedure.

Countries

South Korea

Contacts

Primary ContactJee Youn Moon, MD, PhD
jymoon0901@gmail.com82220722952
Backup ContactYongjae Yoo, MD, PhD
rkdarkef@gmail.com82220722952

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026