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Thoracic Sympathetic Ganglion Block Inadvertent Spread

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ClinicalTrials.gov Identifier: NCT03995576
Recruitment Status : Completed
First Posted : June 24, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Ji Hee Hong, Keimyung University Dongsan Medical Center

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

Condition or disease Intervention/treatment
Thoracic; Sympathetic Ganglion, Injury Other: thoracic sympathetic ganglion block

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 53 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence of Inadvertent Intercostal or Epidural Spread During Thoracic Sympathetic Ganglion Block
Actual Study Start Date : January 3, 2019
Actual Primary Completion Date : August 12, 2019
Actual Study Completion Date : August 12, 2019

Intervention Details:
  • Other: thoracic sympathetic ganglion block
    thoracic sympathetic ganglion block which needle reaches posterolateral vertebral body


Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
severe unilateral arm pain or edema which is intractable to conservative therapy
Criteria

Inclusion Criteria:

  • complex regional pain syndrome
  • lymphedema after breast cancer surgery

Exclusion Criteria:

  • coagulopathy
  • infection
  • previous spine fusion at thoracic level

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995576


Locations
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Korea, Republic of
Hong ji HEE
Daegu, Korea, Republic of, 42601
Ji Hee Hong
Daegu, Korea, Republic of, 700712
Sponsors and Collaborators
Keimyung University Dongsan Medical Center
Investigators
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Principal Investigator: Ji Hee Hong, PhD Keimyung University

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Responsible Party: Ji Hee Hong, Professor, Keimyung University Dongsan Medical Center
ClinicalTrials.gov Identifier: NCT03995576     History of Changes
Other Study ID Numbers: 2019-05-028-004
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Ganglion Cysts
Synovial Cyst
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases