Thoracic Sympathetic Ganglion Block Inadvertent Spread

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

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

Study Overview

• Status: Completed
• Conditions: Thoracic; Sympathetic Ganglion, Injury
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 42601
    • Hong ji HEE
  • Daegu, Korea, Republic of, 700712
    • Ji Hee Hong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

severe unilateral arm pain or edema which is intractable to conservative therapy

Description

Inclusion Criteria:

• complex regional pain syndrome
• lymphedema after breast cancer surgery

Exclusion Criteria:

• coagulopathy
• infection
• previous spine fusion at thoracic level

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of intercostal spread	intercostal spread which appears at fluorosopic view after contrast medium injection	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
incidence of epidural spread	epidural spread which appears at fluorosopic view after contrast medium injection	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
degree of finger tip skin temperature increase	Skin temperature measurement which is observed after successful sympathetic block	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

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2019
• Primary Completion (Actual): August 12, 2019
• Study Completion (Actual): August 12, 2019

Study Registration Dates

• First Submitted: June 20, 2019
• First Submitted That Met QC Criteria: June 20, 2019
• First Posted (Actual): June 24, 2019

Study Record Updates

• Last Update Posted (Actual): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Cysts; Connective Tissue Diseases; Mucinoses; Ganglion Cysts; Synovial Cyst
• Other Study ID Numbers: 2019-05-028-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No