Incidence of Intravascular (IV) Injection During Trigeminal Nerve Blocks

Trigeminal Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04467398
• Other study ID #: 2004-207-1120
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

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

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