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Comparison of Tuohy Needle and Quincke Needle During Caudal Epidural Injection

NCT ID: NCT05504590

Last Updated: 2022-12-27

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

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-31

Study Completion Date

2022-12-21

Brief Summary

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Park et al. reported the results of a randomized study of the use of ultrasound and the use of C-arm in caudal epidural block. However, it is difficult to determine the overall epidural space contrast agent spread with ultrasound alone, and intravascular injection can be avoided with ultrasound. It was said that the evidence for the efficacy of exclusion of intravascular infusion was not as good as that of the C-arm. Therefore, it was suggested that ultrasound in caudal epidural block should be considered only when it is difficult to use the C-arm as an auxiliary means to guide the needle when the sacral hiatus is less than 2 mm and has a complex anatomical structure. The purpose of this study is to determine the difference between intravascular injection and epidural spread according to the type of needle during caudal block under ultrasound guidance.

Detailed Description

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Conditions

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Caudal Epidural Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Double

Study Groups

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Tuohy needle group

Ultrasound-guided caudal epidural block with Touhy needle

Group Type EXPERIMENTAL

Tuohy needle group

Intervention Type DEVICE

Ultrasound-guided caudal epidural block with Touhy needle

Quincke needle group

Ultrasound-guided caudal epidural block with Quincke needle

Group Type ACTIVE_COMPARATOR

Quincke needle group

Intervention Type DEVICE

Ultrasound-guided caudal epidural block with Quincke needle

Interventions

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Tuohy needle group

Ultrasound-guided caudal epidural block with Touhy needle

Intervention Type DEVICE

Quincke needle group

Ultrasound-guided caudal epidural block with Quincke needle

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. A patient who visited the pain clinic complaining of lower back pain due to lumbar disc/stenosis
2. When NRS of back and/or radiating pain is 4 or more
3. Patients over 19 years of age

Exclusion Criteria

1. Malignancy
2. Systemic infection
3. Bleeding tendency
4. Contrast Allergy
5. Pregnant women
6. If you cannot read or agree to the consent form
7. If you cannot sign the consent form yourself
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Do-Hyeong Kim

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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GangnamSeverance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kim JY, Lee JS, Kim JY, Baek JW, Kim HS, Kim DH. Comparison of the incidence of intravascular injection using the Tuohy and Quincke needles during ultrasound-guided caudal epidural block: a prospective randomized controlled study. Reg Anesth Pain Med. 2024 Jan 11;49(1):17-22. doi: 10.1136/rapm-2023-104504.

Reference Type DERIVED
PMID: 37169489 (View on PubMed)

Other Identifiers

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3-2022-0238

Identifier Type: -

Identifier Source: org_study_id