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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Chronic
• Intervention / Treatment: Procedure: 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. 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

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 42601
    • Hong Ji Hee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: upper lumbar ESPB group; Group where ESPB is performed at L2 with local anesthetic mixture 20 ml	Procedure: Erector spinae plane block; fascial plane injection guided by fluoroscopy device
Active Comparator: lower lumbar ESPB group; Group where ESPB is performed at L4 with local anesthetic mixture 20 ml	Procedure: Erector spinae plane block; fascial plane injection guided by fluoroscopy device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
spread level in the cranio-caudal direction	fluoroscopic contrast medium spread level in the cranio-caudal direction	baseline, 1 minute after ESPB

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2022
• Primary Completion (Actual): February 24, 2023
• Study Completion (Actual): February 24, 2023

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 4, 2022

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Pain, Lumbar, Spread
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: Keimyung Medical School

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No