Incidence of Intravascular (IV) Injection During Trigeminal Nerve Blocks

Study Overview
=================
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.

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

Conditions
-----------------
Trigeminal Neuralgia, Facial Pain, Postherpetic Neuralgia, Cluster Headache

Intervention / Treatment
-----------------
* Procedure: trigeminal nerve block


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tuohy needle group<br>The participants who undergo the trigeminal nerve block using 22 guage Tuohy needle. | Procedure: trigeminal nerve block<br>* Trigeminal nerve or branch block using 22 gauge Quincke or Tuohy needle under fluoroscopic guidance.<br>|
| Quincke needle group<br>The participants who undergo the trigeminal nerve block using 22 guage Quincke needle. | Procedure: trigeminal nerve block<br>* Trigeminal nerve or branch block using 22 gauge Quincke or Tuohy needle under fluoroscopic guidance.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IV uptake prevalence (%) | The incidence of intravascular injection during the procedure by digital subtraction angiography(DSA). | During the procedure | 

Secondary Outcome Measures

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