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CompletedNCT05487339Updated Feb 27, 2023

Comparison of Pain Relief After Upper and Lower Lumbar Erector Spinae Plane Block

An interventional study of Erector spinae plane block in Pain, Chronic, sponsored by Keimyung University Dongsan Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-27.

Sponsored by Keimyung University Dongsan Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Pain, Chronic

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Keywords

  • Pain, Lumbar, Spread
03

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 699 are open to participants now.

This study's enrollment of 84 is above the median of 60 across 2,160 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Keimyung University Dongsan Medical Center is the lead sponsor of 81 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
84 participants (actual)

Study arms

  • Active comparator
    upper lumbar ESPB group

    Group where ESPB is performed at L2 with local anesthetic mixture 20 ml

    Procedure: Erector spinae plane block

  • Active comparator
    lower lumbar ESPB group

    Group where ESPB is performed at L4 with local anesthetic mixture 20 ml

    Procedure: Erector spinae plane block

Interventions

  • ProcedureErector spinae plane block

    fascial plane injection guided by fluoroscopy device

06

What researchers measure

Primary outcomes

  1. Numerical rating scale changes among 5 times period

    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

  2. back pain function scale changes among 2 times period

    back pain function scale changes after ESPB among 2 times period

    Time frame: baseline, 4 weeks after ESPB

Secondary outcomes

  1. spread level in the cranio-caudal direction

    fluoroscopic contrast medium spread level in the cranio-caudal direction

    Time frame: baseline, 1 minute after ESPB

07

Study locations

1 site
  • Hong ji HEE
    Daegu, 42601, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05487339
Lead sponsor
Keimyung University Dongsan Medical Center
Responsible party
Ji Hee Hong (Professor, Keimyung University Dongsan Medical Center) — Principal investigator
First posted
Aug 4, 2022
Start date
Aug 12, 2022
Primary completion
Feb 24, 2023
Completion
Feb 24, 2023
Last update
Feb 27, 2023

Study contacts

Ji H Hong, Ph.D
principal investigator · Keimyung University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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