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

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

Study Overview

• Status: Recruiting
• Conditions: Facial Pain; Cluster Headache; Trigeminal Neuralgia; Postherpetic Neuralgia
• Intervention / Treatment: Procedure: trigeminal nerve block

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Jee Youn Moon, MD, PhD; Phone Number: 82220722952; Email: jymoon0901@gmail.com
• Study Contact Backup: Name: Yongjae Yoo, MD, PhD; Phone Number: 82220722952; Email: rkdarkef@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Principal Investigator: Jee Youn Moon, M.D.
    • Contact: Jee Youn Moon, M.D.; Phone Number: 82-10-5299-2036; Email: jymoon0901@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The patients who scheduled to undergo trigeminal nerve block because of:

1. Trigeminal neuralgia/neuropathy
2. Postherpetic trigeminal neuralgia
3. Atypical facial pain
4. Cluster headache

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tuohy needle group; The participants who undergo the trigeminal nerve block using 22 guage Tuohy needle.	Procedure: trigeminal nerve block; Trigeminal nerve or branch block using 22 gauge Quincke or Tuohy needle under fluoroscopic guidance.
Quincke needle group; The participants who undergo the trigeminal nerve block using 22 guage Quincke needle.	Procedure: trigeminal nerve block; Trigeminal nerve or branch block using 22 gauge Quincke or Tuohy needle under fluoroscopic guidance.

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

Collaborators and Investigators

• Sponsor: Seoul National University

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2020
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): June 15, 2024

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Headache Disorders, Primary; Headache Disorders; Facial Nerve Diseases; Trigeminal Autonomic Cephalalgias; Trigeminal Nerve Diseases; Facial Neuralgia; Neuralgia; Headache; Facial Pain; Cluster Headache; Trigeminal Neuralgia; Neuralgia, Postherpetic
• Other Study ID Numbers: 2004-207-1120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No