Incidence of Intravascular (IV) Injection During Trigeminal Nerve Blocks

Recruiting

• Conditions: Cluster Headache; Trigeminal Neuralgia; Postherpetic Neuralgia; Facial Pain
• Interventions: Procedure: trigeminal nerve block

• Registration Number: NCT04467398
• Lead Sponsor: Seoul National University

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.

Study Timeline

• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-07-08
• Study First Posted: 2020-07-13
• Study Start: 2020-07-20
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-04
• Primary Completion: 2024-06-15
• Study Completion: 2024-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tuohy needle group	trigeminal nerve block	The participants who undergo the trigeminal nerve block using 22 guage Tuohy needle.
Quincke needle group	trigeminal nerve block	The participants who undergo the trigeminal nerve block using 22 guage Quincke needle.

Primary Outcome Measures

Name	Time	Method
IV uptake prevalence (%)	During the procedure	The incidence of intravascular injection during the procedure by digital subtraction angiography(DSA).

Secondary Outcome Measures

Name	Time	Method
Laterality	During the procedure	The difference in incidence by the lateriality.
Post-procedure pain	Within 1 hour after the procedure.	NRS pain score after the procedure in recovery room
Total incidence of blood aspiration	During the procedure	Total incidence of blood aspiration by regurgitation.
Total amount of radiation exposure for the procedure.	During the procedure	Total amount of radiation exposure for the procedure.
Final pattern of the fluoroscopic image	During the procedure	The quality of the image(3: excellent, 2: acceptable, 1: not relevant)
Difference in incidence of intravascular injection	During the procedure	Difference in incidence of intravascular injection according to needle type by DSA.
The number of needle adjustment.	During the procedure	The number of needle adjustment due to the intravascular uptake.
Total incidence of intravascular injection	During the procedure	Total incidence of intravascular injection under non-DSA technique.
Total volume of local anesthetics for skin anesthesia.	During the procedure	Total volume of local anesthetics for skin anesthesia.
The difficulty of the procedure	Within 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 aspiration	During the procedure.	Difference in incidence of intravascular injection according to needle type by regurgitation.
The difference in incidence of intravascular injection.	During the procedure	Difference in incidence of intravascular injection according to needle type by non-DSA technique.
The depth of inserted needle when the practitioner check the intravascular uptake under DSA technique.	During the procedure	The depth of inserted needle when the practitioner check the intravascular uptake under SDA technique.
Time for the procedure.	During the procedure	Time for the procedure.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of