Thoracic Sympathetic Ganglion Block Inadvertent Spread

Completed

• Conditions: Thoracic; Sympathetic Ganglion, Injury

• Registration Number: NCT03995576
• Lead Sponsor: Keimyung University Dongsan Medical Center

Brief Summary

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

• Study First Submitted: 2019-06-20
• Study First Submitted QC: 2019-06-20
• Study Start: 2019-06-23
• Study First Posted: 2019-06-24
• Primary Completion: 2019-08-12
• Study Completion: 2019-08-12
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• complex regional pain syndrome
• lymphedema after breast cancer surgery

Exclusion Criteria

• coagulopathy
• infection
• previous spine fusion at thoracic level

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of intercostal spread	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
incidence of epidural spread	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

Name	Time	Method
degree of finger tip skin temperature increase	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

Trial Locations

Locations (2)

Ji Hee Hong; 🇰🇷 Daegu, Korea, Republic of

Hong ji HEE; 🇰🇷 Daegu, Korea, Republic of