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OpenTrials
Completed

NCT Number: NCT05723393

Sympatholytic Effect of Thoracic ESP

The primary endpoint of this study was to identify if erector spinae plane bloock (ESPB) demonstrates any sympatholytic effect.

The secondary endpoint of this study was to compare the changes of PI value between responders and non-responders.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ji Hoon Park

Daegu, 42601, South Korea

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. 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.

ESPB can achieve analgesic effect by blocking the ventral and doramal ramus and possibly by diffusion into paravertebral space. In constrast to lumar region, thoracic paravertebral space is very close to the sympathetic chain. Therefore, sympatholytic effect might be achieved by thoracic ESPB. No previous study has demonstrated the sympatholytic effect of ESPB.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Complex regional pain syndrome
  • Post-thoracotomy pain syndrome
  • Cervical foraminal stenosis
  • Cervical disc herniation
  • Herpes zoster

Exclusion criteria

  • Pregnacy
  • Coagulation abormality
  • Previous spine surgery
  • Allergy to local anesthetics

Treatment and study plan

Erector Spinae Plane Block

Procedure

fascial plane injection guided by ultrasound

Primary outcomes

  1. Perfusion index changes among 4 times period

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

    Perfusion index changes after T2 ESPB among 4 times period

  2. Numerical rating scale changes among 3 times period

    Time frame: baseline, 30 minutes after ESPB, 2 weeks after ESPB

    Numerical rating scale changes among 3 times period

  3. Perfusion index ratio at 10 minutes

    Time frame: baseline, 10minutes after ESPB

    Perfusion index ratio at 10 minutes

Sponsors and collaborators

Lead sponsor

Keimyung University Dongsan Medical Center

Other

Registry information

Official study title

Sympatholytic Effect of High Thoracic Erector Spinae Plane Block

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2023
Registry last updated
Jul 12, 2023

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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