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OpenTrials
Completed

NCT Number: NCT04204720

A Comparison of Intravascular Injection With Chiba Needle and Whitacre Needle

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kyungpook National University Hospital

Daegu, 700-721, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

needle (Chiba)

Device

intravascular injection using chiba needle during caudal epidural block

needle (Whitacre)

Device

intravascular injection using whitacre needle during caudal epidural block

Primary outcomes

  1. incidence of intravascular injection

    Time frame: 5 minute

    incidence of intravascular injection during caudal block

Sponsors and collaborators

Lead sponsor

Kyungpook National University Hospital

Other

Registry information

Official study title

A Comparison of Intravascular Injection With Chiba Needle and Whitacre Needle During Caudal Epidural Block : a Prospective Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2019
Registry last updated
Dec 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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