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Clinical Trials/NCT06471907
NCT06471907
Recruiting
Not Applicable

Comparison of Pain Relief and Peripheral Perfusion Index Using Different Volume of Erector Spinae Plane Block

Keimyung University Dongsan Medical Center1 site in 1 country64 target enrollmentJune 13, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Erector Spinea Plane Block
Sponsor
Keimyung University Dongsan Medical Center
Enrollment
64
Locations
1
Primary Endpoint
Numerical rating scale changes among 5 times period
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The primary endpoint of this study is to compare the pain relief and peripheral perfusion index using different volume of local anesthetics in 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. Perfusion index is an indirect method which can present the degree of peripheral perfusion. Moreover, it is known as a more sensitive measurement tool than the rise of skin temperature. The apply of perfusion index is very simple and noninvasive. The degree of PI increase has been used to determine the success of peripheral nerve block. The volume of local anesthetics has been used 10-30 ml. However, most effective dosage with proper pain relief has never been suggested.

Registry
clinicaltrials.gov
Start Date
June 13, 2024
End Date
April 30, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ji Hee Hong

Professor

Keimyung University Dongsan Medical Center

Eligibility Criteria

Inclusion Criteria

  • lumbar disc herniation
  • lumbar foraminal stenosis
  • lumbar central stenosis
  • lumbar spondylolisthesis
  • numerical rating scale \> 4
  • back pain functional scale \< 45
  • duration of pain \> 1 mon
  • patients who can fully understand all items described in back pain functional scale

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

Outcomes

Primary Outcomes

Numerical rating scale changes among 5 times period

Time Frame: Baseline, 2 weeks, 4 weeks, 8 weeks after the completion of erector spine plane block

minimum (1) and maximum value (10), lower score means better outcome

Secondary Outcomes

  • Perfusion index changes among 4 times period(baseline, 10minutes after ESPB, 20 minutes after ESPB, 30 minutes after ESPB)
  • back pain functional scale among 3 times period(Baseline, 4 weeks, 8 weeks after the completion of erector spine plane block)

Study Sites (1)

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