A Comparison of Intravascular Injection With Chiba Needle and Whitacre Needle

Not Applicable

Completed

• Conditions: Spinal Stenosis Lumbar; Disk Herniated Lumbar
• Interventions: Device: needle (Chiba); Device: needle (Whitacre)

• Registration Number: NCT04204720
• Lead Sponsor: Kyungpook National University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-04-01
• Status Verified: 2019-12
• Primary Completion: 2019-12-15
• Study Completion: 2019-12-15
• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2019-12-18
• Last Update Submitted: 2019-12-18
• Study First Posted: 2019-12-19
• Last Update Posted: 2019-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Chiba	needle (Chiba)	Group chiba receives the chiba needle during caudal block
Group Whitacre	needle (Whitacre)	Group whitacre receives the whitacre needle during caudal block

Primary Outcome Measures

Name	Time	Method
incidence of intravascular injection	5 minute	incidence of intravascular injection during caudal block

Trial Locations

Locations (1)

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of