Comparison of Pain Relief and Peripheral Perfusion Index Using Different Volume of Erector Spinae Plane Block
Comparison of Pain Relief and Peripheral Perfusion Index
Sponsors
Source
Keimyung University Dongsan Medical Center
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Brief Summary
The primary endpoint of this study is to compare the pain relief and peripheral perfusion
index using different volume of local anesthetics in erector spinae plane block.
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. Perfusion index is an indirect
method which can present the degree of peripheral perfusion. Moreover, it is known as a
more sensitive measurement tool than the rise of skin temperature. The apply of perfusion
index is very simple and noninvasive. The degree of PI increase has been used to
determine the success of peripheral nerve block. The volume of local anesthetics has been
used 10-30 ml. However, most effective dosage with proper pain relief has never been
suggested.
Overall Status
Recruiting
Start Date
2024-06-13
Completion Date
2025-04-30
Primary Completion Date
2025-04-30
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Numerical rating scale changes among 5 times period |
Baseline, 2 weeks, 4 weeks, 8 weeks after the completion of erector spine plane block |
Secondary Outcome
Measure |
Time Frame |
|
back pain functional scale among 3 times period |
Baseline, 4 weeks, 8 weeks after the completion of erector spine plane block |
|
Perfusion index changes among 4 times period |
baseline, 10minutes after ESPB, 20 minutes after ESPB, 30 minutes after ESPB |
Enrollment
64
Condition
Intervention
Intervention Type
Procedure
Intervention Name
Description
fascial plane injection using ultrasound
Arm Group Label
10 ml lumbar ESPB group
20 ml lumbar ESPB group
Eligibility
Criteria
Inclusion Criteria:
- lumbar disc herniation
- lumbar foraminal stenosis
- lumbar central stenosis
- lumbar spondylolisthesis
- numerical rating scale > 4
- back pain functional scale < 45
- duration of pain > 1 mon
- patients who can fully understand all items described in back pain functional scale
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
Gender
All
Minimum Age
20 Years
Maximum Age
80 Years
Healthy Volunteers
No
Overall Contact
Last Name
Ji H Hong
Phone
01046794343
swon13@daum.net
Location
Facility |
Status |
Contact |
|
Hong ji HEE Daegu 1835329 42601 South Korea |
Recruiting |
Last Name: J Hee Hong Phone: 82-53-258-7767 Email: swon13@daum.net |
Location Countries
Country
South Korea
Verification Date
2024-07-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Keimyung University Dongsan Medical Center
Investigator Full Name
Ji Hee Hong
Investigator Title
Professor
Has Expanded Access
No
Number Of Arms
2
Arm Group
Arm Group Label
10 ml lumbar ESPB group
Arm Group Type
Placebo Comparator
Description
lumbar ESPB was performed with 10 ml of local anesthetics
Arm Group Label
20 ml lumbar ESPB group
Arm Group Type
Experimental
Description
lumbar ESPB was performed with 20 ml of local anesthetics
Firstreceived Results Date
N/A
Overall Contact Backup
Last Name
Ji Hoon Park
Phone
0532587760
cmjihoon@gmail.com
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)
Study First Submitted
June 18, 2024
Study First Submitted Qc
June 18, 2024
Study First Posted
June 24, 2024
Last Update Submitted
July 2, 2024
Last Update Submitted Qc
July 2, 2024
Last Update Posted
July 5, 2024
ClinicalTrials.gov processed this data on November 26, 2025
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.