Analysis of Injectate Spread During Erector Spinae Block
Comparison of the Spread Level During Thoracic Erector Spinae Plane Block Using Two Volumes of Local Anesthetics
1 other identifier
interventional
159
1 country
2
Brief Summary
The primary purpose of this study was to identify the ESPB spread level in the craniocaudal direction when performed at the T2 level. The secondary purpose was to determine the incidence of spread into epidural, paravertebral, intercostal, and intravascular injections with ESPB
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Feb 2022
2 active sites
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
February 10, 2022
CompletedStudy Start
First participant enrolled
February 21, 2022
CompletedFirst Posted
Study publicly available on registry
March 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2022
CompletedDecember 20, 2022
December 1, 2022
8 months
February 10, 2022
December 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
spread level in the cranio-caudal direction
fluoroscopic contrast medium spread level in the cranio-caudal direction
baseline, 1 minutes after erector spinae plane block
Secondary Outcomes (4)
Number of participant showing epidural spread
baseline, 1 minute after erector spinae plane block
Number of participant showing intercostal spread
baseline, 1 minute after erector spinae plane block
Number of participant showing paravertebral spread
baseline, 1 minute after erector spinae plane block
Number of participant showing intravascular spread
baseline, 1 minute after erector spinae plane block
Study Arms (2)
10 ml ESP group
EXPERIMENTALESP group using 10 ml mixture of local anesthetics and contrast medium using ultrasound and fluoroscopy
20 ml ESP group
EXPERIMENTALESP group using 20 ml mixture of local anesthetics and contrast medium using ultrasound and fluoroscopy
Interventions
fascial plane injection using ultrasound and fluoroscopic guidance
Eligibility Criteria
You may qualify if:
- Cervical facet joint arthrosis
- Cervical foraminal stenosis
- Cervical herniated intervertebral disc
- myofascial pain syndrome of upper back muscle
You may not qualify if:
- Allergy to local anesthetics or contrast medium
- Pregnancy
- Prior history of cervical spine surgery
- Coagulation abnormality
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hong ji HEE
Daegu, 42601, South Korea
Ji Hee Hong
Daegu, 700712, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ji H Hong
Keimyung University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 10, 2022
First Posted
March 15, 2022
Study Start
February 21, 2022
Primary Completion
October 30, 2022
Study Completion
October 30, 2022
Last Updated
December 20, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share