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Comparison of Pain Relief and Peripheral Perfusion Index

Not Applicable
Recruiting
Conditions
Erector Spinea Plane Block
Interventions
Procedure: erector spinae plane block
Registration Number
NCT06471907
Lead Sponsor
Keimyung University Dongsan Medical Center
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
64
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
10 ml lumbar ESPB grouperector spinae plane blocklumbar ESPB was performed with 10 ml of local anesthetics
20 ml lumbar ESPB grouperector spinae plane blocklumbar ESPB was performed with 20 ml of local anesthetics
Primary Outcome Measures
NameTimeMethod
Numerical rating scale changes among 5 times periodBaseline, 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 Outcome Measures
NameTimeMethod
Perfusion index changes among 4 times periodbaseline, 10minutes after ESPB, 20 minutes after ESPB, 30 minutes after ESPB

erfusion index changes after lumbar ESPB among 4 times period

back pain functional scale among 3 times periodBaseline, 4 weeks, 8 weeks after the completion of erector spine plane block

minimum (0) and maximum value (60), higher score means better outcome

Trial Locations

Locations (1)

Hong ji HEE

🇰🇷

Daegu, Korea, Republic of

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