A Comparison of Intravascular Injection With Chiba Needle and Whitacre Needle

Kyungpook National University

Status: Completed

Conditions: Spinal Stenosis Lumbar; Disk Herniated Lumbar

Treatments: Device: needle (Whitacre); Device: needle (Chiba)

Study type: Interventional

Funder types: Other

Identifiers

NCT04204720

2018-06-007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 164 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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164 participants in 2 patient groups

Group Whitacre

Active Comparator group

Description:

Group whitacre receives the whitacre needle during caudal block

Treatment:

Device: needle (Whitacre)

Group Chiba

Experimental group

Description:

Group chiba receives the chiba needle during caudal block

Treatment:

Device: needle (Chiba)