NCT04204720

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2019

Completed
Last Updated

December 19, 2019

Status Verified

December 1, 2019

Enrollment Period

1.7 years

First QC Date

December 17, 2019

Last Update Submit

December 18, 2019

Conditions

Spinal Stenosis LumbarDisk Herniated Lumbar

Outcome Measures

Primary Outcomes (1)

  • incidence of intravascular injection

    incidence of intravascular injection during caudal block

    5 minute

Study Arms (2)

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

needle (Chiba)DEVICE

intravascular injection using chiba needle during caudal epidural block

Group Chiba
needle (Whitacre)DEVICE

intravascular injection using whitacre needle during caudal epidural block

Group Whitacre

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with low back pain and/or leg radicular pain under diagnoses as disc herniation or spinal stenosis

You may not qualify if:

  • allergy to local anesthetics or contrast medium, coagulopathy, local infection at the injection site, and systemic infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

MeSH Terms

Interventions

Needles

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Younghoon Jeon

    Kyungpook National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 17, 2019

First Posted

December 19, 2019

Study Start

April 1, 2018

Primary Completion

December 15, 2019

Study Completion

December 15, 2019

Last Updated

December 19, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)