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Clinical Trials/NCT05723367
NCT05723367
Recruiting
Not Applicable

Perfusion Index Value in Predicting the Clinical Outcome of Lumbar ESPB

Keimyung University Dongsan Medical Center1 site in 1 country85 target enrollmentFebruary 13, 2023
ConditionsPain, Chronic

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain, Chronic
Sponsor
Keimyung University Dongsan Medical Center
Enrollment
85
Locations
1
Primary Endpoint
Number of patients showing numerical rating scale reduction more than 50%
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
February 13, 2023
End Date
November 30, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ji Hee Hong

Professor

Keimyung University Dongsan Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of patients showing numerical rating scale reduction more than 50%

Time Frame: 1 month after erector spinae plane block

Number of patients showing numerical rating scale reduction more than 50%

Number of patients showing no reduction in numerical rating scale

Time Frame: 1 month after erector spinae plane block

Number of patients showing no reduction in numerical rating scale

Back pain functional scale between 2 time periods

Time Frame: baseline, 1 month after erector spinae plane block

Back pain functional scale between 2 time periods

Perfusion index changes among 4 time periods

Time Frame: baseline, 10 minutes after erector spinae plane block, 20 minutes after erector spinae plane block, 30 minutes after erector spinae plane block

Perfusion index changes among 4 time periods

Number of patients showing numerical rating scale reduction less than 50%

Time Frame: 1 month after erector spinae plane block

Number of patients showing numerical rating scale reduction less than 50%

Study Sites (1)

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