Incidence of Intravascular (IV) Injection During Trigeminal Nerve Blocks

NCT04467398 | Unknown

• 1 other identifier: 2004-207-1120
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Trigeminal Neuralgia; Facial Pain; Postherpetic Neuralgia; Cluster Headache

Outcome Measures

Primary Outcomes (1)

• IV uptake prevalence (%)

  The incidence of intravascular injection during the procedure by digital subtraction angiography(DSA).

  During the procedure

Secondary Outcomes (14)

• Difference in incidence of intravascular injection

  During the procedure

• Total incidence of blood aspiration

  During the procedure

• Total incidence of intravascular injection

  During the procedure

• The depth of inserted needle when the practitioner check the intravascular uptake under DSA technique.

  During the procedure

• The number of needle adjustment.

  During the procedure

Study Arms (2)

Tuohy needle group

The participants who undergo the trigeminal nerve block using 22 guage Tuohy needle.

Procedure: trigeminal nerve block

Quincke needle group

The participants who undergo the trigeminal nerve block using 22 guage Quincke needle.

Procedure: trigeminal nerve block

Interventions

trigeminal nerve block PROCEDURE

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

Quincke needle group; Tuohy needle group

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• The patients who scheduled to undergo trigeminal nerve block due to the facial pain

You may not qualify if:

• Refusal of the patient
• Pregnancy
• Coagulopathy
• Local or systemic infection
• Allergy to injectate
• Anatomical deformation of the skull

Sponsors & Collaborators

• Seoul National University: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases

Central Study Contacts

Jee Youn Moon, MD, PhD

CONTACT

82220722952; jymoon0901@gmail.com

Yongjae Yoo, MD, PhD

CONTACT

82220722952; rkdarkef@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: July 13, 2020
• Study Start: July 20, 2020
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: August 4, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)