Comparison of Pain Relief After Upper and Lower Lumbar Erector Spinae Plane Block
Comparison of Pain Relief and Spread Level in Upper and Lower Lumbar Erector Spinae Plane Block
1 other identifier
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2022
CompletedFirst Posted
Study publicly available on registry
August 4, 2022
CompletedStudy Start
First participant enrolled
August 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2023
CompletedFebruary 27, 2023
February 1, 2023
7 months
August 1, 2022
February 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Numerical rating scale changes among 5 times period
numerical rating scale changes after ESPB among 5 times period
baseline, 10 minutes after ESPB, 1 week after ESPB, 2 weeks after ESPB, 4 weeks after ESPB
back pain function scale changes among 2 times period
back pain function scale changes after ESPB among 2 times period
baseline, 4 weeks after ESPB
Secondary Outcomes (1)
spread level in the cranio-caudal direction
baseline, 1 minute after ESPB
Study Arms (2)
upper lumbar ESPB group
ACTIVE COMPARATORGroup where ESPB is performed at L2 with local anesthetic mixture 20 ml
lower lumbar ESPB group
ACTIVE COMPARATORGroup where ESPB is performed at L4 with local anesthetic mixture 20 ml
Interventions
fascial plane injection guided by fluoroscopy device
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hong ji HEE
Daegu, 42601, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ji H Hong, Ph.D
Keimyung University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 1, 2022
First Posted
August 4, 2022
Study Start
August 12, 2022
Primary Completion
February 24, 2023
Study Completion
February 24, 2023
Last Updated
February 27, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share