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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04467398
Other study ID # 2004-207-1120
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 20, 2020
Est. completion date June 15, 2024

Study information

Verified date August 2023
Source Seoul National University
Contact Jee Youn Moon, MD, PhD
Phone 82220722952
Email jymoon0901@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to investigate the incidence of intravascular injection during trigeminal nerve blocks.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date June 15, 2024
Est. primary completion date June 15, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years to 85 Years
Eligibility 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


Intervention

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

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary IV uptake prevalence (%) The incidence of intravascular injection during the procedure by digital subtraction angiography(DSA). During the procedure
Secondary Difference in incidence of intravascular injection Difference in incidence of intravascular injection according to needle type by DSA. During the procedure
Secondary Total incidence of blood aspiration Total incidence of blood aspiration by regurgitation. During the procedure
Secondary Total incidence of intravascular injection Total incidence of intravascular injection under non-DSA technique. During the procedure
Secondary 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
Secondary The number of needle adjustment. The number of needle adjustment due to the intravascular uptake. During the procedure
Secondary Total volume of local anesthetics for skin anesthesia. Total volume of local anesthetics for skin anesthesia. During the procedure
Secondary Time for the procedure. Time for the procedure. During the procedure
Secondary Total amount of radiation exposure for the procedure. Total amount of radiation exposure for the procedure. During the procedure
Secondary Laterality The difference in incidence by the lateriality. During the procedure
Secondary Final pattern of the fluoroscopic image The quality of the image(3: excellent, 2: acceptable, 1: not relevant) During the procedure
Secondary Post-procedure pain NRS pain score after the procedure in recovery room Within 1 hour after the procedure.
Secondary 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.
Secondary The difference in incidence of blood aspiration Difference in incidence of intravascular injection according to needle type by regurgitation. During the procedure.
Secondary The difference in incidence of intravascular injection. Difference in incidence of intravascular injection according to needle type by non-DSA technique. During the procedure
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