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Completed

NCT Number: NCT03995576

Thoracic Sympathetic Ganglion Block Inadvertent Spread

This study wants to identify the incidence of inadvertend intercostal or epidural spread of thoracic sympathetic block

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hong ji HEE, Daegu, South Korea

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About this study

Clinically, sympathetic blocks (SB) have been used widely to relieve the symptoms of SMP or to differentiate between SMP and sympathetically independent pain. In order to an SB has a diagnostic value, it requires the successful disturbance of the sympathetic activity for a proper duration of time.

For the diagnosis of SMP using an SB, it is essential achieving complete interruption of the sympathetic activity while preserving the sensory and motor function. The sympathetic trunk at lumbar region runs on the anterolateral surface of the vertebral column from L1 to L4 levels, and deep to the medial aspect of the psoas major muscle. Therefore, the investigators can hardly find epidural contrast spread during lumbar SB due to an anterior location of lumbar sympathetic ganglion to the lateral vertebral body. However, frequent psoas muscle injection can be encountered due to a close proximity of lumbar sympathetic ganglion.

In contrast to lumbar sympathetic ganglion, the thoracic sympathetic ganglion is not separated from somatic nerves by muscles and connective tissue. Moreover, the upper thoracic ganglion runs on the posterior surface of vertebral column with close proximity to adjacent epidural region.

This difference of thoracic sympathetic ganglion leads to a frequent epidural and intercostal spread if the investigators perform thoracic SB. Such spread to epidural and intercostal space lowers the diagnostic value of thoracic SB. In addition, serious adverse outcome can be encountered if neurolytic agent is injected into epidural or intercostal space for the purpose of thoracic sympathectomy. Considering the diagnostic value and safety of thoracic SB, evaluation of actual incidence of occurrence of intercostal and epidural spread is important.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • complex regional pain syndrome
  • lymphedema after breast cancer surgery

Exclusion criteria

  • coagulopathy
  • infection
  • previous spine fusion at thoracic level

Treatment and study plan

thoracic sympathetic ganglion block

Other

thoracic sympathetic ganglion block which needle reaches posterolateral vertebral body

Primary outcomes

  1. incidence of intercostal spread

    Time frame: 60 seconds after the completion of thoracic sympathetic ganglion block. 60 seconds means the time when the outcome was measured after thoracic sympathetic ganglion block

    intercostal spread which appears at fluorosopic view after contrast medium injection

  2. incidence of epidural spread

    Time frame: 60 seconds after the completion of thoracic sympathetic ganglion block. 60 seconds means the time when the outcome was measured after thoracic sympathetic ganglion block

    epidural spread which appears at fluorosopic view after contrast medium injection

Secondary outcomes

  1. degree of finger tip skin temperature increase

    Time frame: 5, 10, 15, 20 minutes after the completion of the intervention 5, 10, 15, 20 minutes mean the time that the outcome was measured after performing the intervention

    Skin temperature measurement which is observed after successful sympathetic block

Sponsors and collaborators

Lead sponsor

Keimyung University Dongsan Medical Center

Other

Registry information

Official study title

Incidence of Inadvertent Intercostal or Epidural Spread During Thoracic Sympathetic Ganglion Block

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 24, 2019
Registry last updated
Sep 20, 2019

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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