Analysis of Spread Level During Thoracic Erector Spinae Block
Primary Purpose
Pain, Radiculopathy, Cervical
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Erector spinae plane block
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
Inclusion Criteria:
- cervical facet joint arthrosis
- cervical foraminal stenosis
- cervical herniated intervertebral disc
- myofascial pain syndrome of upper back muscle
Exclusion Criteria:
- allergy to local anesthetics or contrast medium
- pregnancy
- prior history of cervical spine surgery
- coagulation abnormality
Sites / Locations
- Hong ji HEE
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
10 ml ESPB group
20 ml ESPB group
Arm Description
ESPB group using 10 ml mixture of local anesthetics and contrast medium using ultrasound and fluoroscopy
ESPB group using 20 ml mixture of local anesthetics and contrast medium using ultrasound and fluoroscopy
Outcomes
Primary Outcome Measures
spread level in the cranio-caudal direction
fluoroscopic contrast medium spread level in the cranio-caudal direction
Secondary Outcome Measures
Number of participant showing epidural spread
Number of participant showing epidural spread by analysis of fluoroscopic image
Number of participant showing intercostal spread
Number of participant showing intercostal spread by analysis of fluoroscopic image
Number of participant showing paravertebral spread
Number of participant showing paravertebral spread by analysis of fluorosocpic image
Number of participant showing intravascular spread
Number of participants showing intravascular spread by analysis of fluoroscopic image
Full Information
NCT ID
NCT05082220
First Posted
September 30, 2021
Last Updated
December 22, 2022
Sponsor
Keimyung University Dongsan Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05082220
Brief Title
Analysis of Spread Level During Thoracic Erector Spinae Block
Official Title
Comparison of the Spread Level During Thoracic Erector Spinae Plane Block Using Two Volumes of Local Anesthetics
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 21, 2022 (Actual)
Primary Completion Date
October 30, 2022 (Actual)
Study Completion Date
October 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keimyung University Dongsan Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
The ESPB requires ultrasound guidance which enables visible local anesthetic spread underneath the erector spinae muscles. The spinalis, longissimus thoracis, and iliocostalis muscles comprise the ES muscles, which run vertically along both sides of the vertebral column from the sacrum up to the skull base. The ESPB can be performed in the cervical, thoracic, and lumbar regions. Among them, upper or mid thoracic ESPB has been used more widely compared to cervical and lumbar regions. Previous cadaveric studies on the ESPB at the T5 level using computed tomography (CT) reconstruction or direct dissection demonstrated the extensive craniocaudal distribution of methylene blue ranging from T1 to T8 vertebral segments deep to the ES muscles and variable involvement of epidural, paravertebral, and intercostal spaces. The ESPB performed at the T2 level of the cadaver demonstrated an injected dye distribution ranging from C4 to T10. Also, 36% of cadavers showed the spread of an injected dye to the ventral, dorsal ramus, paravertebral space, and even the contralateral side. The exact mechanism of action of ESPB remains unclear. A recent study suggested that the analgesic effect of ESPB could be obtained by blocking the ventral and dorsal ramus of the spinal nerves by passing through the costotransverse foramen. However, in clinical practice, we can encounter highly variable clinical outcomes or sensory block after the ESPB. The study of the physical spread of the injected agent can be used to predict the clinical result and elucidate the possible mechanism of action of ESPB.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Radiculopathy, Cervical
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
157 (Actual)
8. Arms, Groups, and Interventions
Arm Title
10 ml ESPB group
Arm Type
Experimental
Arm Description
ESPB group using 10 ml mixture of local anesthetics and contrast medium using ultrasound and fluoroscopy
Arm Title
20 ml ESPB group
Arm Type
Experimental
Arm Description
ESPB group using 20 ml mixture of local anesthetics and contrast medium using ultrasound and fluoroscopy
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Intervention Description
fascial plane injection using ultrasound and fluoroscopic guidance
Primary Outcome Measure Information:
Title
spread level in the cranio-caudal direction
Description
fluoroscopic contrast medium spread level in the cranio-caudal direction
Time Frame
Baseline, 5 minutes after erector spinae plane block
Secondary Outcome Measure Information:
Title
Number of participant showing epidural spread
Description
Number of participant showing epidural spread by analysis of fluoroscopic image
Time Frame
baseline, 5 minute after erector spinae plane block
Title
Number of participant showing intercostal spread
Description
Number of participant showing intercostal spread by analysis of fluoroscopic image
Time Frame
baseline, 5 minute after erector spinae plane block
Title
Number of participant showing paravertebral spread
Description
Number of participant showing paravertebral spread by analysis of fluorosocpic image
Time Frame
baseline, 5 minute after erector spinae plane block
Title
Number of participant showing intravascular spread
Description
Number of participants showing intravascular spread by analysis of fluoroscopic image
Time Frame
baseline, 5 minute after erector spinae plane block
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
cervical facet joint arthrosis
cervical foraminal stenosis
cervical herniated intervertebral disc
myofascial pain syndrome of upper back muscle
Exclusion Criteria:
allergy to local anesthetics or contrast medium
pregnancy
prior history of cervical spine surgery
coagulation abnormality
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji H Hong
Organizational Affiliation
Keimyung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hong ji HEE
City
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Analysis of Spread Level During Thoracic Erector Spinae Block
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