Comparison of Pain Relief Between High Thoracic Erector Spinae Plane Block and Cervical Epidural Injection
Primary Purpose
Pain, Chronic
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Erector spinae plane block
cervical epidural injection
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Chronic focused on measuring Pain, lumbar
Eligibility Criteria
Inclusion Criteria:
- cervical spinal stenosis
- cervical disc herniation
- cervical facet arthropathy
- myofascial pain syndrome of upper back muscle
- herpes zoster
- postherpetic neuralgia
Exclusion Criteria:
- Allergy to local anesthetics or contrast medium
- Pregnancy
- Spine deformity
- Patients with coagulation abnormality
Sites / Locations
- Hong ji HEERecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
high thoracic ESPB group
cervical epidural group
Arm Description
Group where ESPB is performed at T2 with local anesthetic mixture 20 ml
Group where cervical epidural injection is performed at C6-7 or C7-T1 level
Outcomes
Primary Outcome Measures
Changes of numerical rating scale
Changes of 11-point numerical rating scale (0-10)
Secondary Outcome Measures
Changes of neck disability index
Changes of back pain funtional scale
Full Information
NCT ID
NCT05487326
First Posted
August 1, 2022
Last Updated
April 2, 2023
Sponsor
Keimyung University Dongsan Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05487326
Brief Title
Comparison of Pain Relief Between High Thoracic Erector Spinae Plane Block and Cervical Epidural Injection
Official Title
Comparison of Pain Relief Between High Thoracic Erector Spinae Plane Block and Cervical Epidural Injection
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
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 whether there is a pain improving effect of high thoracic eretor spinae plane block (ESPB) when compared with cervical epidural injection
Detailed Description
The erector spinae plane block (ESPB) is a less invasive, safer, and technically easy alternative procedure to conventional neuraxial anesthetic techniques. In contrast to common neuraxial techniques such as paravertebral and epidural injections, the ESPB targets an interfascial plane which is far from the spinal cord, root, and pleura. First applied to thoracic neuropathic pain, currently ESPB is being applied to postoperative pain control and includes variable clinical situations. In the abdomen and thoracic wall, thoracic ESPB can be applied for pain control after cardiac surgery, video-assisted thoracic surgery, laparoscopic cholecystectomy, and thoracotomy. Recently, favorable postoperative pain control after lumbar spinal or lower limb surgeries has been reported with lumbar ESPB. In addition, ESPB has also been used for chronic pain conditions in the upper and lower extremities. To investigate the possible mechanism of action of the ESPB, many previous studies have focused on examining the physical spread of the injected agent. Commonly, contrast dye injections in human cadavers have been utilized to assess the spread level. Physical spread level was determined using various methods including direct dissection or sectioning, computed tomography (CT), thoracoscopic inspection, or magnetic resonance imaging (MRI) with radiocontrast injection. Apart from human cadaver studies, physical spread level has been evaluated in alive patients using a variable volume of local anesthetics mixed with radiocontrast. However, these studies are limited by the small number of included patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic
Keywords
Pain, lumbar
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
high thoracic ESPB group
Arm Type
Active Comparator
Arm Description
Group where ESPB is performed at T2 with local anesthetic mixture 20 ml
Arm Title
cervical epidural group
Arm Type
Active Comparator
Arm Description
Group where cervical epidural injection is performed at C6-7 or C7-T1 level
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Intervention Description
fascial plane injection guided by ultrasound guidance
Intervention Type
Procedure
Intervention Name(s)
cervical epidural injection
Intervention Description
cervical epidural injection by fluoroscopy
Primary Outcome Measure Information:
Title
Changes of numerical rating scale
Description
Changes of 11-point numerical rating scale (0-10)
Time Frame
baseline, 10 min after injection, 1wk after injection, 2 wks after injection, 4 wks after injection, 8 wks after injection
Secondary Outcome Measure Information:
Title
Changes of neck disability index
Description
Changes of back pain funtional scale
Time Frame
baseline, 8 wks after injection
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 spinal stenosis
cervical intervertebral disc herniation
cervical facet arthropathy
cervical foraminal stenosis
Exclusion Criteria:
Allergy to local anesthetics or contrast medium
Pregnancy
Spine deformity
Patients with coagulation abnormality
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji H Hong, Ph.D
Phone
01046794343
Email
swon13@daum.net
First Name & Middle Initial & Last Name or Official Title & Degree
Sung W Jung
Phone
01021064343
Email
swon12@daum.net
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J Hee Hong
Phone
82-53-258-7767
Email
swon13@daum.net
12. IPD Sharing Statement
Learn more about this trial
Comparison of Pain Relief Between High Thoracic Erector Spinae Plane Block and Cervical Epidural Injection
We'll reach out to this number within 24 hrs