An interventional study of Ultrasound and Fluoroscopy in Chronic Pain, Neuropathic Pain and Complex Regional Pain Syndromes, sponsored by Seoul National University. Not yet recruiting. Open to participants aged 19 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by Seoul National University · Not applicable, Interventional, and Treatment
For patients scheduled to undergo upper limb sympathetic nerve block due to chronic neuropathic pain in the upper limb lasting more than 3 months, the ultrasound-guided stellate ganglion block group (S group) and the fluoroscopy-guided thoracic sympathetic nerve block group (T) Patients are randomly assigned 1:1 to one of the groups, and the procedure is performed. To evaluate the effectiveness of sympathetic nerve blockade, temperature changes in both palms are measured twice, 20 minutes before and 20 minutes after the procedure, using an infrared thermographer. Other variables related to the procedure are surveyed by outpatient visit or telephone before the procedure, after the procedure, before returning home, and 1 week and 1 month after the procedure.
Patients aged 19 to 85 with upper limb pain are directly informed about the study, recruited, and enrolled at the Seoul National University Hospital Pain Center.
Before and after the procedure, continuous monitoring of electrocardiography, blood pressure, pulse rate, and oxygen saturation is carried out.
Before undergoing thoracic sympathetic ganglion block (TSGB) guided by fluoroscopy or ultrasound-guided stellate ganglion block (SGB), the temperature of both palms is measured using an infrared thermometer. Prior to the procedure, Doppler mode ultrasound equipment is used to measure blood flow velocity in the upper limb arteries (brachial artery).
In the case of ultrasound-guided stellate ganglion block, the patient is placed in a supine position, and the procedure is performed using ultrasound guidance to inject 5 mL of 1% mepivacaine at the level of C6. For fluoroscopy-guided thoracic sympathetic ganglion block, the patient is positioned prone, and 3 mL of 1% mepivacaine is injected at the level of T3. In both cases, the procedure is performed by a specialist with a rank of professor or higher who specializes in pain management.
After the procedure, the palm temperature is measured again 20 minutes later using an infrared thermometer.
Blood flow velocity in the upper limb arteries (brachial artery) is also measured 20 minutes post-procedure using Doppler mode ultrasound equipment.
Additionally, various procedure-related variables are assessed through outpatient visits or telephone surveys conducted before the procedure, at discharge, one week post-procedure, and four weeks post-procedure.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's planned enrollment of 118 is above the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Seoul National University is the lead sponsor of 32 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
In the case of ultrasound-guided stellate ganglion block, the patient is made to lie down and stellate ganglion block is performed by injecting 5 mL of 1% mepivacaine at the level of the 6th cervical vertebra using ultrasound.
Device: Ultrasound
In the case of fluoroscopic device-guided thoracic sympathetic nerve block, place the patient prone and inject 3 mL of 1% mepivacaine at the level of the third thoracic vertebra to perform thoracic sympathetic nerve block.
Device: Fluoroscopy
Ultrasound-guided stellate ganglion block with 1% mepivacaine 5 mL
Fluoroscopic-guided thoracic sympathetic ganglion block with 1% mepivacaine 3 mL
(1) Proportion of patients reaching > 1.5°C rise of temperature in the ipsilateral hand compared to the contralateral hand
\[ipsilateral hand temperature after the block - ipsilateral hand temperature before the block\] - \[contralateral hand temperature after the block - contralateral hand temperature before the block\]
Time frame: 20 minutes after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
(1) Difference of temperature change (°C) between ipsilateral hand and contralateral hand
\[ipsilateral hand temperature after the block - ipsilateral hand temperature before the block\] - \[contralateral hand temperature after the block - contralateral hand temperature before the block\]
Time frame: 20 minutes after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
(2) Severity of pain
11-point numerical rating scale (NRS)
Time frame: Time before block and 20 minutes and 1 week and 4weeks after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
(3) Patient satisfaction (PGIC scale)
5-point Likert Scale
Time frame: 20 minutes and 1 week and 4 weeks after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
(4) Comparison of Korean version CISS(Cold Intolerance Symptom Severity) Questionnaire
Time frame: Time before block and 4 weeks after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
(5) Blood flow velocity measurement in upper extremity vessel(ipsilateral brachial artery) using ultrasound
cm/s
Time frame: Time before block and 20minutes after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
No study locations are listed for this record.
Start is estimated for Jul 2024; primary completion for Dec 2025, 17 months later.
Of 1,295 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's planned 17 months is below that.
Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.
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This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Seoul National University