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A Comparison of Intravascular Injection With Chiba Needle and Whitacre Needle

NCT ID: NCT04204720

Last Updated: 2019-12-19

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

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-12-15

Brief Summary

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Caudal epidural injection (CEI) is effective for spinal pain. However, intravascular injection may occur during CEI, which can lead to hematoma, neurologic deficit and local anesthetics systemic toxicity. Whitacre type needle has been reported to be effective for reducing intravascular injection during transforaminal epidural injection. In this study, we compared the Chiba needle and Whitacre needle on incidence of intravascular injection during CEI.

Detailed Description

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A total of 164 caudal epidural injections were performed in patients with disc herniation or spinal stenosis on lumbosacral region. Patients were randomly allocated to Group Whitacre (n=82) and Group Chiba (n=82). Patients in Group Whitacre received caudal epidural injection using Whitacre type needle and those in Group Chiba received the procedure using Chiba type needle. Intravascular injection was assessed with blood aspiration and angiography during real-time fluoroscopy.

Conditions

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Spinal Stenosis Lumbar Disk Herniated Lumbar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group Whitacre

Group whitacre receives the whitacre needle during caudal block

Group Type ACTIVE_COMPARATOR

needle (Whitacre)

Intervention Type DEVICE

intravascular injection using whitacre needle during caudal epidural block

Group Chiba

Group chiba receives the chiba needle during caudal block

Group Type EXPERIMENTAL

needle (Chiba)

Intervention Type DEVICE

intravascular injection using chiba needle during caudal epidural block

Interventions

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needle (Chiba)

intravascular injection using chiba needle during caudal epidural block

Intervention Type DEVICE

needle (Whitacre)

intravascular injection using whitacre needle during caudal epidural block

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients with low back pain and/or leg radicular pain under diagnoses as disc herniation or spinal stenosis

Exclusion Criteria

* allergy to local anesthetics or contrast medium, coagulopathy, local infection at the injection site, and systemic infection
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyungpook National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Younghoon Jeon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Younghoon Jeon

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital

Locations

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Kyungpook National University Hospital

Daegu, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2018-06-007

Identifier Type: -

Identifier Source: org_study_id