Comparison of Pain Relief After Upper and Lower Lumbar Erector Spinae Plane Block
Primary Purpose
Pain, Chronic
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, Chronic focused on measuring Pain, Lumbar, Spread
Eligibility Criteria
Inclusion Criteria:
- lumbar disc herniation
- lumbar muscular sprain
- lumbar myofascial pain syndrome
- lumbar spinal stenosis
Exclusion Criteria:
- Allergy to local anesthetics or contrast medium
- Pregnancy
- Spine deformity
- Patients with coagulation abnormality
Sites / Locations
- Hong ji HEE
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
upper lumbar ESPB group
lower lumbar ESPB group
Arm Description
Group where ESPB is performed at L2 with local anesthetic mixture 20 ml
Group where ESPB is performed at L4 with local anesthetic mixture 20 ml
Outcomes
Primary Outcome Measures
Numerical rating scale changes among 5 times period
numerical rating scale changes after ESPB among 5 times period
back pain function scale changes among 2 times period
back pain function scale changes after 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
NCT ID
NCT05487339
First Posted
August 1, 2022
Last Updated
February 23, 2023
Sponsor
Keimyung University Dongsan Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05487339
Brief Title
Comparison of Pain Relief After Upper and Lower Lumbar Erector Spinae Plane Block
Official Title
Comparison of Pain Relief and Spread Level in Upper and Lower Lumbar Erector Spinae Plane Block
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 12, 2022 (Actual)
Primary Completion Date
February 24, 2023 (Actual)
Study Completion Date
February 24, 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 eretor spinae plane block (ESPB) has any effect in relieving low back pain or leg pain in lumbar radiculopathy. The secondary endpoint was to compare the number of spread level when upper or lower lumbar ESPB was performed.
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. Therefore, the exact spread level of injected local anesthetics remains unclear and a study on a large number of patients is still required
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic
Keywords
Pain, Lumbar, Spread
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
upper lumbar ESPB group
Arm Type
Active Comparator
Arm Description
Group where ESPB is performed at L2 with local anesthetic mixture 20 ml
Arm Title
lower lumbar ESPB group
Arm Type
Active Comparator
Arm Description
Group where ESPB is performed at L4 with local anesthetic mixture 20 ml
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Intervention Description
fascial plane injection guided by fluoroscopy device
Primary Outcome Measure Information:
Title
Numerical rating scale changes among 5 times period
Description
numerical rating scale changes after ESPB among 5 times period
Time Frame
baseline, 10 minutes after ESPB, 1 week after ESPB, 2 weeks after ESPB, 4 weeks after ESPB
Title
back pain function scale changes among 2 times period
Description
back pain function scale changes after ESPB among 2 times period
Time Frame
baseline, 4 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 ESPB
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:
lumbar disc herniation
lumbar foraminal stenosis
lumbar central stenosis
lumbar spondylolisthesis
severe level of spine at L3-4
numerical rating scale > 4
back pain functional scale < 45
duration of pain > 1 month
patients who can fully understand all items described in BPFS
Exclusion Criteria:
Allergy to local anesthetics or contrast medium
Pregnancy
Spine deformity
Prior history of lumbar spine surgery
No previous lumbar MRI or CT
Patients with coagulation abnormality
Incorrect level of ESPB
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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Comparison of Pain Relief After Upper and Lower Lumbar Erector Spinae Plane Block
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