A Comparison of Intravascular Injection With Chiba Needle... | NCT04204720

Studies
A Comparison of Intravascular Injection With Chiba Needle and Whitacre Needle

NCT04204720

Sponsor

Kyungpook National University Hospital

Status

Completed

Last Update Posted

Dec 19, 2019Actual

Enrollment

164Actual

Phase

Not Applicable

Conditions

Spinal Stenosis Lumbar
Disk Herniated Lumbar

Interventions

needle (Chiba)
needle (Whitacre)

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2018Actual

Primary Completion Date

Dec 15, 2019Actual

Completion Date

Dec 15, 2019Actual

First Submitted Date

Dec 17, 2019

First Submission Date that Met QC Criteria

Dec 18, 2019

First Posted Date

Dec 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2019

Last Update Posted Date

Dec 19, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Younghoon Jeon, Professor, Kyungpook National University HospitalPrincipal Investigator

Lead Sponsor

Kyungpook National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

164Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group Whitacre	Active Comparator	Group whitacre receives the whitacre needle during caudal block	Device: needle (Whitacre)
Group Chiba	Experimental	Group chiba receives the chiba needle during caudal block	Device: needle (Chiba)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
needle (Chiba)	Device	intravascular injection using chiba needle during caudal epidural block	Group Chiba

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of intravascular injection	incidence of intravascular injection during caudal block	5 minute

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Younghoon Jeon	Kyungpook National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyungpook National University Hospital		Daegu		700-721	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided