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Thoracic Sympathetic Ganglion Block Inadvertent Spread
| Condition or disease | Intervention/treatment |
|---|---|
| Thoracic; Sympathetic Ganglion, Injury | Other: thoracic sympathetic ganglion block |
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 |
| 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 : | June 23, 2019 |
| Actual Primary Completion Date : | August 12, 2019 |
| Actual Study Completion Date : | August 12, 2019 |
- 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
- 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
- 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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 20, 2019 | ||||
| First Posted Date | June 24, 2019 | ||||
| Last Update Posted Date | September 20, 2019 | ||||
| Actual Study Start Date | June 23, 2019 | ||||
| Actual Primary Completion Date | August 12, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures |
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| Change History | |||||
| Current Secondary Outcome Measures |
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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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Thoracic Sympathetic Ganglion Block Inadvertent Spread | ||||
| Official Title | Incidence of Inadvertent Intercostal or Epidural Spread During Thoracic Sympathetic Ganglion Block | ||||
| 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. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | severe unilateral arm pain or edema which is intractable to conservative therapy | ||||
| Condition | Thoracic; Sympathetic Ganglion, Injury | ||||
| Intervention | Other: thoracic sympathetic ganglion block
thoracic sympathetic ganglion block which needle reaches posterolateral vertebral body
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| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
53 | ||||
| Original Estimated Enrollment |
36 | ||||
| Actual Study Completion Date | August 12, 2019 | ||||
| Actual Primary Completion Date | August 12, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 20 Years to 80 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Korea, Republic of | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03995576 | ||||
| Other Study ID Numbers | 2019-05-028-004 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Ji Hee Hong, Keimyung University Dongsan Medical Center | ||||
| Study Sponsor | Keimyung University Dongsan Medical Center | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Keimyung University Dongsan Medical Center | ||||
| Verification Date | September 2019 | ||||
