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NCT04204720 Clinical Trial

A Comparison of Intravascular Injection With Chiba Needle and Whitacre Needle

Spinal Stenosis Lumbar Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04204720
Other study ID # 2018-06-007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2018
Est. completion date December 15, 2019

Study information
Verified date December 2019
Source Kyungpook National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 164
Est. completion date December 15, 2019
Est. primary completion date December 15, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• needle (Chiba)
intravascular injection using chiba needle during caudal epidural block
• needle (Whitacre)
intravascular injection using whitacre needle during caudal epidural block

Locations
Country Name City State
Korea, Republic of Kyungpook National University Hospital Daegu

Sponsors (1)
Lead Sponsor Collaborator
Kyungpook National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of intravascular injection incidence of intravascular injection during caudal block 5 minute
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