Intravascular Injection Rate During Lumbar Transforaminal Epidural Block Using Bent or Straight Needles
The Difference of Intravascular Injection Rate During Lumbar Transforaminal Epidural Block Using Bent Needle Compared to Straight Needle: a Prospective Study
1 other identifier
interventional
260
1 country
1
Brief Summary
The primary aim of this study was to compare intravascular injection rates during LTFESI between commonly used straight and bent chiba needles.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
April 27, 2023
CompletedStudy Start
First participant enrolled
April 27, 2023
CompletedFirst Posted
Study publicly available on registry
May 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMay 8, 2023
May 1, 2023
7 months
April 27, 2023
May 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Intravascular injection
Intravascular injection is defined as contrast media spreading out through the vascular channel during injection of contrast media under real time fluoroscopy
During procedure
Secondary Outcomes (3)
Ventral epidural spreading
up to 24 weeks
Medial epidural spreading
up to 24 weeks
Procedure time
During procedure
Study Arms (2)
Straight needle
EXPERIMENTAL25 gauge straight chiba needle
Bent needle
ACTIVE COMPARATOR25 gauge bent chiba needle
Interventions
Lumbar transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of lumbar radicular pain. During lumbar transforaminal epidural steroid injection, straight needle is going to be used.
Lumbar transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of lumbar radicular pain. During lumbar transforaminal epidural steroid injection, bent needle is going to be used.
Eligibility Criteria
You may qualify if:
- Patients with radiating pain from lumbar spinal stenosis and herniated nucleus pulposus.
You may not qualify if:
- Pregnancy, allergic to contrast media, patient refusal, and patients with persistent contraindication to nerve block such as coagulopathy and infection of the injection site.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyungpook national university hospital
Daegu, 700-412, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Saeyoung Kim
Kyungpook National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 27, 2023
First Posted
May 8, 2023
Study Start
April 27, 2023
Primary Completion
November 30, 2023
Study Completion
December 31, 2023
Last Updated
May 8, 2023
Record last verified: 2023-05