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Completed

NCT Number: NCT05280847

Analysis of Injectate Spread During Erector Spinae Block

The primary purpose of this study was to identify the ESPB spread level in the craniocaudal direction when performed at the T2 level. The secondary purpose was to determine the incidence of spread into epidural, paravertebral, intercostal, and intravascular injections with ESPB

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hong ji HEE, Daegu, South Korea

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About this study

The ESPB requires ultrasound guidance which enables visible local anesthetic spread underneath the erector spinae muscles. The spinalis, longissimus thoracis, and iliocostalis muscles comprise the ES muscles, which run vertically along both sides of the vertebral column from the sacrum up to the skull base. The ESPB can be performed in the cervical, thoracic, and lumbar regions. Among them, upper or mid thoracic ESPB has been used more widely compared to cervical and lumbar regions. Previous cadaveric studies on the ESPB at the T5 level using computed tomography (CT) reconstruction or direct dissection demonstrated the extensive craniocaudal distribution of methylene blue ranging from T1 to T8 vertebral segments deep to the ES muscles and variable involvement of epidural, paravertebral, and intercostal spaces. The ESPB performed at the T2 level of the cadaver demonstrated an injected dye distribution ranging from C4 to T10. Also, 36% of cadavers showed the spread of an injected dye to the ventral, dorsal ramus, paravertebral space, and even the contralateral side. The exact mechanism of action of ESPB remains unclear. A recent study suggested that the analgesic effect of ESPB could be obtained by blocking the ventral and dorsal ramus of the spinal nerves by passing through the costotransverse foramen. However, in clinical practice, we can encounter highly variable clinical outcomes or sensory block after the ESPB. The study of the physical spread of the injected agent can be used to predict the clinical result and elucidate the possible mechanism of action of ESPB.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Cervical facet joint arthrosis
  • Cervical foraminal stenosis
  • Cervical herniated intervertebral disc
  • myofascial pain syndrome of upper back muscle

Exclusion criteria

  • Allergy to local anesthetics or contrast medium
  • Pregnancy
  • Prior history of cervical spine surgery
  • Coagulation abnormality

Treatment and study plan

Erector Spinae Plane Block

Procedure

fascial plane injection using ultrasound and fluoroscopic guidance

Other names: ESP

Primary outcomes

  1. spread level in the cranio-caudal direction

    Time frame: baseline, 1 minutes after erector spinae plane block

    fluoroscopic contrast medium spread level in the cranio-caudal direction

Secondary outcomes

  1. Number of participant showing epidural spread

    Time frame: baseline, 1 minute after erector spinae plane block

    Number of participant showing epidural spread by analysis of fluoroscopic image

  2. Number of participant showing intercostal spread

    Time frame: baseline, 1 minute after erector spinae plane block

    Number of participant showing intercostal spread by analysis of fluoroscopic image

  3. Number of participant showing paravertebral spread

    Time frame: baseline, 1 minute after erector spinae plane block

    Number of participant showing paravertebral spread by analysis of fluorosocpic image

  4. Number of participant showing intravascular spread

    Time frame: baseline, 1 minute after erector spinae plane block

    Number of participants showing intravascular spread by analysis of fluoroscopic image

Sponsors and collaborators

Lead sponsor

Keimyung University Dongsan Medical Center

Other

Registry information

Official study title

Comparison of the Spread Level During Thoracic Erector Spinae Plane Block Using Two Volumes of Local Anesthetics

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 15, 2022
Registry last updated
Dec 20, 2022

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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