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NCT Number: NCT06471907

Comparison of Pain Relief and Peripheral Perfusion Index

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.

Recruiting

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erector Spinae Plane Block

Procedure

fascial plane injection using ultrasound

Primary outcomes

  1. 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

  1. back pain functional scale among 3 times period

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

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

  2. Perfusion index changes among 4 times period

    Time frame: baseline, 10minutes after ESPB, 20 minutes after ESPB, 30 minutes after ESPB

    erfusion index changes after lumbar ESPB among 4 times period

Study contacts

Contact information is provided by the study sponsor or research team.

Ji H Hong

CONTACT

[email protected]

01046794343

Ji Hoon Park

CONTACT

[email protected]

0532587760

Sponsors and collaborators

Lead sponsor

Keimyung University Dongsan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2024
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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