- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05487313
Pain Relief After High Thoracic Eretor Spinae Block
Comparison of Pain Relief During High Thoracic Erector Spinae Plane Block Using Different Volumes of Local Anesthetics
Study Overview
Status
Conditions
Intervention / Treatment
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 (1,10). 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Daegu, Korea, Republic of, 42601
- Hong ji HEE
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 10 ml ESP group
ESP group using 10 ml mixture of local anesthetics and contrast medium
|
fascial plane injection guided by fluoroscopic device after ultrasound guidance
|
Active Comparator: 20 ml ESP group
ESP group using 20 ml mixture of local anesthetics and contrast medium
|
fascial plane injection guided by fluoroscopic device after ultrasound guidance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
numerical rating scale changes among 5 times period
Time Frame: baseline, 10 minutes after ESPB, 1 week after ESPB, 2 weeks after ESPB, 4 weeks after ESPB, 8 weeks after ESPB
|
numerical rating scale changes after T2 ESPB among 5 times period
|
baseline, 10 minutes after ESPB, 1 week after ESPB, 2 weeks after ESPB, 4 weeks after ESPB, 8 weeks after ESPB
|
Neck disability scale changes
Time Frame: baseline, 8 weeks after ESPB
|
Neck disability scale changes after T2 ESPB among 2 times period
|
baseline, 8 weeks after ESPB
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
spread level in the cranio-caudal direction
Time Frame: baseline, 1 minute after erector spinae plane block
|
fluoroscopic contrast medium spread level in the cranio-caudal direction
|
baseline, 1 minute after erector spinae plane block
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-01-026-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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