Neuropathic Pain Clinical Trial
Official title:
The Comparison of Sympathetic Blockade of Stellate Ganglion Block and Thoracic Paravertebral Block in Patients With Chronic Upper Extremity Neuropathic Pain: a Prospective Randomized and Comparative Clinical Trial
Verified date | October 2023 |
Source | Seoul National University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to investigate the effect of ultrasound-guided thoracic paravertebral block (TPVB) when performing sympathetic block for upper limb pain control.
Status | Completed |
Enrollment | 69 |
Est. completion date | January 16, 2023 |
Est. primary completion date | December 19, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 85 Years |
Eligibility | Inclusion Criteria: - Clinical diagnosis of complex regional pain syndrome - Clinical diagnosis of postherpetic neuralgia - Clinical diagnosis of phantom limb pain - Clinical diagnosis of chronic post-surgical pain - Clinical diagnosis of post-traumatic pain syndrome - Upper extremity pain lasting more than 3 months Patients with a new or known diagnosis of chronic neuropathic pain lasting more than 3 months in the upper extremity Exclusion Criteria: - Refusal of a patient - Any vascular disease in the upper extremities - Previous history of thoracic sympathetic or stellate ganglion neurolysis (e.g. -thermocoagulation, radiofrequency neuromodulation, and/or chemical neurolysis) - Coagulopathy - Systemic infection or local infection at the needle injection site - Major deformation at the level of the neck (radiotherapy, surgery, etc.) - Known allergy to local anesthetics of amide type - Inability to understand a numeric rating pain scale (cognitive dysfunction) - Patients whose palm temperature on the ipsilateral side is = 36.5? in the thermography before the procedure |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University | SMG-SNU Boramae Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients reaching > 1.5°C rise of temperature in the ipsilateral hand compared to the contralateral hand | Temperature is measured with a laser thermometer on the palmar aspect of 3 cm below from the middle finger. | 20 minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block | |
Secondary | Difference of temperature change (°C) between ipsilateral hand and contralateral hand | Temperature is measured with a laser thermometer on the palmar aspect of 3 cm below from the middle finger. | 20 minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block | |
Secondary | Severity of pain | The severity of the pain will be evaluated before the block and 20 minutes, 1 week and 4 weeks after the block using an 11-pointed NRS (numerical rating scale) pain score. | Time before block and 20 minutes and 1 week and 4weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block | |
Secondary | Patient global impression change (PGIC) | The PGIC will be evaluated 20 minutes, 1 week and 4 weeks after the block using a 5-point Likert scale. | Time 20 minutes and 1 week and 4 weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block | |
Secondary | Comparison of Korean version CISS(Cold Intolerance Symptom Severity) Questionnaire | Check the CISS before the procedure and 4 weeks after the procedure. | Time before block and 4 weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block | |
Secondary | Blood flow velocity measurement in upper extremity vessel(ipsilateral brachial artery) using ultrasound | The blood flow velocity in the ipsilateral brachial artery will be measured before the block and 20 minutes after the block using a Doppler mode ultrasound device. | Time before block and 20minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block |
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