Intravascular Injection Rate During Lumbar Transforaminal Epidural Block Using Bent or Straight Needles

NCT ID: NCT05849324

Last Updated: 2023-05-08

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-27

Study Completion Date

2023-12-31

Brief Summary

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The primary aim of this study was to compare intravascular injection rates during LTFESI between commonly used straight and bent chiba needles.

Detailed Description

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Lumbar transforaminal epidural steroid injection (LTFESI) is widely used in clinical practice to effectively deliver injectate into the ventral epidural space. Complications associated with intravascular injection such as spinal cord infarction and paraplegia can occur during LTFESI. The incidence of intravascular injection during LTFESI was known as 9.9% \~ 17.7%. To improve the safety of the procedure, avoidance of intravascular injection is crucial, for which appropriate needle selection is important. Currently, the most commonly used block needles in LTFESI are straight or bent chiba needles.

The primary aim of this study was to compare intravascular injection rates during LTFESI between commonly used straight and bent chiba needles.

Conditions

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Analgesia, Epidural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Straight needle

25 gauge straight chiba needle

Group Type EXPERIMENTAL

Straight needle

Intervention Type DEVICE

Lumbar transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of lumbar radicular pain. During lumbar transforaminal epidural steroid injection, straight needle is going to be used.

Bent needle

25 gauge bent chiba needle

Group Type ACTIVE_COMPARATOR

Bent needle

Intervention Type DEVICE

Lumbar transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of lumbar radicular pain. During lumbar transforaminal epidural steroid injection, bent needle is going to be used.

Interventions

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Straight needle

Lumbar transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of lumbar radicular pain. During lumbar transforaminal epidural steroid injection, straight needle is going to be used.

Intervention Type DEVICE

Bent needle

Lumbar transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of lumbar radicular pain. During lumbar transforaminal epidural steroid injection, bent needle is going to be used.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with radiating pain from lumbar spinal stenosis and herniated nucleus pulposus.

Exclusion Criteria

* Pregnancy, allergic to contrast media, patient refusal, and patients with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

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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Saeyoung Kim, MD, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saeyoung Kim

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital

Locations

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Kyungpook national university hospital

Daegu, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jimin Heo

Role: CONTACT

+82-53-420-5430

Saeyoung Kim

Role: CONTACT

+82-53-420-5873

Facility Contacts

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Jimin Heo

Role: primary

82-53-420-5430

Other Identifiers

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2023-03-022-001

Identifier Type: -

Identifier Source: org_study_id

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