Incidence of Intravascular (IV) Injection During Trigeminal Nerve Blocks

August 3, 2023 updated by: Jeeyoun Moon, Seoul National University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Jee Youn Moon, M.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
IV uptake prevalence (%)
Time Frame: During the procedure
The incidence of intravascular injection during the procedure by digital subtraction angiography(DSA).
During the procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference in incidence of intravascular injection
Time Frame: During the procedure
Difference in incidence of intravascular injection according to needle type by DSA.
During the procedure
Total incidence of blood aspiration
Time Frame: During the procedure
Total incidence of blood aspiration by regurgitation.
During the procedure
Total incidence of intravascular injection
Time Frame: During the procedure
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.
Time Frame: During the procedure
The depth of inserted needle when the practitioner check the intravascular uptake under SDA technique.
During the procedure
The number of needle adjustment.
Time Frame: During the procedure
The number of needle adjustment due to the intravascular uptake.
During the procedure
Total volume of local anesthetics for skin anesthesia.
Time Frame: During the procedure
Total volume of local anesthetics for skin anesthesia.
During the procedure
Time for the procedure.
Time Frame: During the procedure
Time for the procedure.
During the procedure
Total amount of radiation exposure for the procedure.
Time Frame: During the procedure
Total amount of radiation exposure for the procedure.
During the procedure
Laterality
Time Frame: During the procedure
The difference in incidence by the lateriality.
During the procedure
Final pattern of the fluoroscopic image
Time Frame: During the procedure
The quality of the image(3: excellent, 2: acceptable, 1: not relevant)
During the procedure
Post-procedure pain
Time Frame: Within 1 hour after the procedure.
NRS pain score after the procedure in recovery room
Within 1 hour after the procedure.
The difficulty of the procedure
Time Frame: Within 1 hour after 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
Time Frame: During the procedure.
Difference in incidence of intravascular injection according to needle type by regurgitation.
During the procedure.
The difference in incidence of intravascular injection.
Time Frame: During the procedure
Difference in incidence of intravascular injection according to needle type by non-DSA technique.
During the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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