Prediction of Clinical Outcome in Lumbar ESPB

Perfusion Index Value in Predicting the Clinical Outcome of Lumbar ESPB

The primary endpoint of this study was to identify that Perfusion index (PI) has any predictive value for the treatment outcome of cervical radiculopathy

Study Overview

• Status: Recruiting
• Conditions: Pain, Chronic
• Intervention / Treatment: Procedure: lumbar ESPB group where ESPB is performed at L4 with local anesthetics 20ml

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. The perfusion index (PI) is a numerical value for the ratio between pulsatile and non-pulsatile blood flow measured by a special pulse oximeter. Although the special probe for PI measurement is relatively more expensive compared with ordinary pulse oximetery probes, its benefit as a marker of peripheral perfusion and as an idex for sympathetic stimulation have increased its use progressively. PI has been used widely for the prediction of success of brachial plexus block or axillary block. Changes of PI ratio value showed an excellent predictive value for the success of block.

There have been no studies demonstrating predictive value of PI in lumbar ESPB ESPB for the relief of low back pain or leg pain due to lumbar disc herniation or stenosis.

• Study Type: Observational
• Enrollment (Anticipated): 85

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 42601
    • Recruiting
    • Ji Hoon Park

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

• Sampling Method: Probability Sample

Study Population

Patients who visit the pain clinic

Description

Inclusion Criteria:

• Lumbar foraminal stenosis
• Lumbar central stenosis
• Lumbar disc herniation
• Lumbar spondylolisthesis

Exclusion Criteria:

• Infection
• Pregnancy
• allergy to local anesthetic agnets
• Previous lumbar spine surgery

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perfusion index changes among 4 time periods	Perfusion index changes among 4 time periods	baseline, 10 minutes after erector spinae plane block, 20 minutes after erector spinae plane block, 30 minutes after erector spinae plane block
Number of patients showing numerical rating scale reduction more than 50%	Number of patients showing numerical rating scale reduction more than 50%	1 month after erector spinae plane block
Number of patients showing numerical rating scale reduction less than 50%	Number of patients showing numerical rating scale reduction less than 50%	1 month after erector spinae plane block
Number of patients showing no reduction in numerical rating scale	Number of patients showing no reduction in numerical rating scale	1 month after erector spinae plane block
Back pain functional scale between 2 time periods	Back pain functional scale between 2 time periods	baseline, 1 month after erector spinae plane block

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Anticipated): November 30, 2023
• Study Completion (Anticipated): November 30, 2023

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 10, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 2023-01-025-03

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