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Pain Relief After High Thoracic Eretor Spinae Block

Primary Purpose

Pain, Chronic

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Erector spinae plane block
Sponsored by
Keimyung University Dongsan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Chronic focused on measuring Pain, Cervical, Spread

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Active Comparator

Active Comparator

Arm Label

10 ml ESP group

20 ml ESP group

Arm Description

ESP group using 10 ml mixture of local anesthetics and contrast medium

ESP group using 20 ml mixture of local anesthetics and contrast medium

Outcomes

Primary Outcome Measures

numerical rating scale changes among 5 times period
numerical rating scale changes after T2 ESPB among 5 times period
Neck disability scale changes
Neck disability scale changes after T2 ESPB among 2 times period

Secondary Outcome Measures

spread level in the cranio-caudal direction
fluoroscopic contrast medium spread level in the cranio-caudal direction

Full Information

First Posted
August 1, 2022
Last Updated
March 28, 2023
Sponsor
Keimyung University Dongsan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05487313
Brief Title
Pain Relief After High Thoracic Eretor Spinae Block
Official Title
Comparison of Pain Relief During High Thoracic Erector Spinae Plane Block Using Different Volumes of Local Anesthetics
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 12, 2022 (Actual)
Primary Completion Date
March 21, 2023 (Actual)
Study Completion Date
March 21, 2023 (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 endpoint of this study was to identify if the ESPB in the patients of cervical radiculopathy has the effect of pain relief. The secondary endpoint of this study was to identify the spread level in the craniocaudal direction when performed at the T2 level.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic
Keywords
Pain, Cervical, Spread

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 ml ESP group
Arm Type
Active Comparator
Arm Description
ESP group using 10 ml mixture of local anesthetics and contrast medium
Arm Title
20 ml ESP group
Arm Type
Active Comparator
Arm Description
ESP group using 20 ml mixture of local anesthetics and contrast medium
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Intervention Description
fascial plane injection guided by fluoroscopic device after ultrasound guidance
Primary Outcome Measure Information:
Title
numerical rating scale changes among 5 times period
Description
numerical rating scale changes after T2 ESPB 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
Title
Neck disability scale changes
Description
Neck disability scale changes after T2 ESPB among 2 times period
Time Frame
baseline, 8 weeks after ESPB
Secondary 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, 1 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, Ph.D
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
No

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Pain Relief After High Thoracic Eretor Spinae Block

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