Back to resultsA Comparison of Intravascular Injection With Chiba Needle and Whitacre Needle
Primary Purpose
Spinal Stenosis Lumbar, Disk Herniated Lumbar
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
needle (Chiba)
needle (Whitacre)
Sponsored by
About this trial
This is an interventional prevention trial for Spinal Stenosis Lumbar
Eligibility Criteria
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
Sites / Locations
- Kyungpook National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group Whitacre
Group Chiba
Arm Description
Group whitacre receives the whitacre needle during caudal block
Group chiba receives the chiba needle during caudal block
Outcomes
Primary Outcome Measures
incidence of intravascular injection
incidence of intravascular injection during caudal block
Secondary Outcome Measures
Full Information
NCT ID
NCT04204720
First Posted
December 17, 2019
Last Updated
December 18, 2019
Sponsor
Kyungpook National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04204720
Brief Title
A Comparison of Intravascular Injection With Chiba Needle and Whitacre Needle
Official Title
A Comparison of Intravascular Injection With Chiba Needle and Whitacre Needle During Caudal Epidural Block : a Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 15, 2019 (Actual)
Study Completion Date
December 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis Lumbar, Disk Herniated Lumbar
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group Whitacre
Arm Type
Active Comparator
Arm Description
Group whitacre receives the whitacre needle during caudal block
Arm Title
Group Chiba
Arm Type
Experimental
Arm Description
Group chiba receives the chiba needle during caudal block
Intervention Type
Device
Intervention Name(s)
needle (Chiba)
Intervention Description
intravascular injection using chiba needle during caudal epidural block
Intervention Type
Device
Intervention Name(s)
needle (Whitacre)
Intervention Description
intravascular injection using whitacre needle during caudal epidural block
Primary Outcome Measure Information:
Title
incidence of intravascular injection
Description
incidence of intravascular injection during caudal block
Time Frame
5 minute
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Younghoon Jeon
Organizational Affiliation
Kyungpook National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Comparison of Intravascular Injection With Chiba Needle and Whitacre Needle
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