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Intravascular Injection Rates During Lumbar Medial Branch Block

NCT ID: NCT05020509

Last Updated: 2021-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-12

Study Completion Date

2021-10-30

Brief Summary

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The purpose of this study is to compare using Toughy needle has an advantage of reducing the incidence of vasucular puncture during lumbar medial branch block.

Detailed Description

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In previous reports, the use of Toughy needle was thought to reduce the incidence of intravascular injection during lumbar transforaminal injection. Blunt needles with a pencil point tip, such as Whitacre needles, are not as sharp at their tip as are Quincke needles, which have bevels. Toughy or blunt needles may therefore be less likely to penetrate a vessel during a procedure. Hence, the investigators postulated the incidence of intravenous uptake would be significantly lower using a Toughy needle than using a Quincke needle for lumbar medial branch block. To confirm the intravascular injection rates, the investigators used the real time fluoroscopy after injection of contrast medium.

The goal of this study was to compare the incidence of intravascular injection rate betweeen Toughy and Quincke needles using real time fluoroscopy during lumbar medial branch block

Conditions

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Intravascular Injection

Keywords

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intravascular injection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Touhy needle group

medial branch block with touhy needle

Group Type ACTIVE_COMPARATOR

medial branch block

Intervention Type PROCEDURE

lumbar medial branch block

Quincke needle group

medial branch block with Quincke needle

Group Type PLACEBO_COMPARATOR

medial branch block

Intervention Type PROCEDURE

lumbar medial branch block

Interventions

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medial branch block

lumbar medial branch block

Intervention Type PROCEDURE

Other Intervention Names

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lumbar medial branch block

Eligibility Criteria

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Inclusion Criteria

* facet joint arthropathy

Exclusion Criteria

* allergy to local anesthetics or contrast medium
* pregnancy
* spine deformity
* neurologic abnormality
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Keimyung University Dongsan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ji Hee Hong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hong ji HEE

Daegu, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2021-07-014-001

Identifier Type: -

Identifier Source: org_study_id