Chronic PainNCT06130514
The Comparison of Sympathetic Blockade of Stellate Ganglion Block and Thoracic Sympathetic Ganglion Block
A study testing Ultrasound and Fluoroscopy in people with Chronic Pain and Neuropathic Pain, run by Seoul National University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Chronic Pain, Neuropathic Pain, Complex Regional Pain Syndromes
- What is being tested?
- Ultrasound and Fluoroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2024to 10 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with 19 - 85 years
- Patients with chronic upper extremity pain that lasts for more than 3 months
- Neuropathic pain conditions such as postherpetic neuralgia, complex regional pain syndrome, post laminectomy syndrome of cervical spine
- Patients judged to require sympathetic blockade by pain physician
Who cannot join
- Patient refusal
- Presence of upper limb vascular disorders
- History of previous thoracic sympathetic ganglion removal or neurolysis
- Abnormal findings in blood coagulation tests
- Systemic infection or local injection site infection
- Anatomical deformities at the injection site
Show all 9Show fewer
- Allergic reactions to the injected medications
- Higher baseline hand temperature on the procedure side than the tympanic temperature (36.5°C) on pre-procedure thermography
- Other cases deemed inappropriate by the investigator
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Comparison of Sympathetic Blockade of Stellate Ganglion Block and Thoracic Sympathetic Ganglion Block in Patients With Chronic Upper Extremity Neuropathic Pain: a Prospective Randomized and Comparative Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Chronic Pain, Neuropathic Pain, Complex Regional Pain Syndromes, Post Herpetic Neuralgia, Post Laminectomy Syndrome
- Being tested
- Ultrasound, Fluoroscopy
- Medical subject headings
- Chronic Pain, Neuralgia, Complex Regional Pain Syndromes, Neuralgia, Postherpetic, post laminectomy syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Ultrasound-guided stellate ganglion block with 1% mepivacaine 5 mL
FluoroscopyDevice
Fluoroscopic-guided thoracic sympathetic ganglion block with 1% mepivacaine 3 mL
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided stellate ganglion block (US-guided SGB) | Active comparator | 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. Receives: Device: Ultrasound |
| Fluoroscopy-guided thoracic sympathetic ganglion block (FS-guided TSGB) | Active comparator | 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. Receives: Device: Fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
(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]
Measured: 20 minutes after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
Secondary outcomes (5)
(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]
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Time before block and 20minutes after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start10 Jul 2024 (estimated)
- Primary completion10 Dec 2025 (estimated)
- Study completion10 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyoun Moon, Seoul National University
- Investigators
- Jee Youn Moon, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130514
- Sponsor's protocol ID
- 2309-150-1472
- Status last verified
- May 2024
- First submitted
- 8 Nov 2023
- Last updated
- 29 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim YH, Kim SY, Lee YJ, Kim ED. A Prospective, Randomized Cross-Over Trial of T2 Paravertebral Block as a Sympathetic Block in Complex Regional Pain Syndrome. Pain Physician. 2019 Sep;22(5):E417-E424.
PubMed 31561653Kim J, Yun M, Han AH, Pauzi MF, Jeong JH, Yoo Y, Moon JY. Thoracic sympathetic ganglion blocks: real-world outcomes in 207 chronic pain patients. Reg Anesth Pain Med. 2024 Jul 8;49(7):528-535. doi: 10.1136/rapm-2023-104624.
PubMed 37726196Kim J, Lee HJ, Lee YJ, Lee CS, Yoo Y, Moon JY. Ultrasound-Guided Thoracic Paravertebral Block as a Sympathetic Blockade for Upper Extremity Neuropathic Pain: A Prospective Pilot Study. J Pain Res. 2020 Dec 14;13:3395-3403. doi: 10.2147/JPR.S285998. eCollection 2020.
PubMed 33363406Yoo HS, Nahm FS, Lee PB, Lee CJ. Early thoracic sympathetic block improves the treatment effect for upper extremity neuropathic pain. Anesth Analg. 2011 Sep;113(3):605-9. doi: 10.1213/ANE.0b013e3182274803. Epub 2011 Jul 21.
PubMed 21778335Day M. Sympathetic blocks: the evidence. Pain Pract. 2008 Mar-Apr;8(2):98-109. doi: 10.1111/j.1533-2500.2008.00177.x.
PubMed 18366465Rocha Rde O, Teixeira MJ, Yeng LT, Cantara MG, Faria VG, Liggieri V, Loduca A, Muller BM, Souza AC, de Andrade DC. Thoracic sympathetic block for the treatment of complex regional pain syndrome type I: a double-blind randomized controlled study. Pain. 2014 Nov;155(11):2274-81. doi: 10.1016/j.pain.2014.08.015. Epub 2014 Aug 19.
PubMed 25149143
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Sympathetic Blockade of Stellate Ganglion Block and Thoracic Sympathetic Ganglion Block in Patients With Chronic Upper Extremity Neuropathic Pain: a Prospective Randomized and Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT06130514
- Acronym / sponsor ID
- 2309-150-1472
- Conditions
- Chronic Pain, Neuropathic Pain, Complex Regional Pain Syndromes, Post Herpetic Neuralgia, Post Laminectomy Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Seoul National UniversityUniversity, hospital or other
- Study start
- 10 Jul 2024 (estimated)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 10 Jan 2026 (estimated)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided stellate ganglion block (US-guided SGB) | Active comparator | Device: UltrasoundIn 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. |
| Fluoroscopy-guided thoracic sympathetic ganglion block (FS-guided TSGB) | Active comparator | Device: FluoroscopyIn 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. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients with 19 - 85 years
- Patients with chronic upper extremity pain that lasts for more than 3 months
- Neuropathic pain conditions such as postherpetic neuralgia, complex regional pain syndrome, post laminectomy syndrome of cervical spine
- Patients judged to require sympathetic blockade by pain physician
Key exclusion criteria (9 listed)
- Patient refusal
- Presence of upper limb vascular disorders
- History of previous thoracic sympathetic ganglion removal or neurolysis
- Abnormal findings in blood coagulation tests
- Systemic infection or local injection site infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundUltrasound-guided stellate ganglion block with 1% mepivacaine 5 mL | Device | Ultrasound-guided stellate ganglion block (US-guided SGB) |
| FluoroscopyFluoroscopic-guided thoracic sympathetic ganglion block with 1% mepivacaine 3 mL | Device | Fluoroscopy-guided thoracic sympathetic ganglion block (FS-guided TSGB) |
Primary outcome
(1) Proportion of patients reaching > 1.5°C rise of temperature in the ipsilateral hand compared to the contralateral hand
Time frame: 20 minutes after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
[ipsilateral hand temperature after the block - ipsilateral hand temperature before the block] - [contralateral hand temperature after the block - contralateral hand temperature before the block]
5 secondary outcomes
(1) Difference of temperature change (°C) between ipsilateral hand and contralateral hand
Time frame: 20 minutes after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
(2) Severity of pain
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)
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
Time frame: Time before block and 20minutes after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Background: PubMed 31561653Kim YH, Kim SY, Lee YJ, Kim ED. A Prospective, Randomized Cross-Over Trial of T2 Paravertebral Block as a Sympathetic Block in Complex Regional Pain Syndrome. Pain Physician. 2019 Sep;22(5):E417-E424.
- Background: PubMed 37726196Kim J, Yun M, Han AH, Pauzi MF, Jeong JH, Yoo Y, Moon JY. Thoracic sympathetic ganglion blocks: real-world outcomes in 207 chronic pain patients. Reg Anesth Pain Med. 2024 Jul 8;49(7):528-535. doi: 10.1136/rapm-2023-104624.
- Background: PubMed 33363406Kim J, Lee HJ, Lee YJ, Lee CS, Yoo Y, Moon JY. Ultrasound-Guided Thoracic Paravertebral Block as a Sympathetic Blockade for Upper Extremity Neuropathic Pain: A Prospective Pilot Study. J Pain Res. 2020 Dec 14;13:3395-3403. doi: 10.2147/JPR.S285998. eCollection 2020.
- Background: PubMed 21778335Yoo HS, Nahm FS, Lee PB, Lee CJ. Early thoracic sympathetic block improves the treatment effect for upper extremity neuropathic pain. Anesth Analg. 2011 Sep;113(3):605-9. doi: 10.1213/ANE.0b013e3182274803. Epub 2011 Jul 21.
- Background: PubMed 18366465Day M. Sympathetic blocks: the evidence. Pain Pract. 2008 Mar-Apr;8(2):98-109. doi: 10.1111/j.1533-2500.2008.00177.x.
- Background: PubMed 25149143Rocha Rde O, Teixeira MJ, Yeng LT, Cantara MG, Faria VG, Liggieri V, Loduca A, Muller BM, Souza AC, de Andrade DC. Thoracic sympathetic block for the treatment of complex regional pain syndrome type I: a double-blind randomized controlled study. Pain. 2014 Nov;155(11):2274-81. doi: 10.1016/j.pain.2014.08.015. Epub 2014 Aug 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jee Youn Moon, MD, PhD principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound and Fluoroscopy in people with Chronic Pain and Neuropathic Pain, run by Seoul National University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jee Youn Moon, MD, PhD (821052992036, jymoon0901@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(1) Proportion of patients reaching > 1.5°C rise of temperature in the ipsilateral hand compared to the contralateral hand (time frame: 20 minutes after FS-guided thoracic sympathetic ganglion block or US-guided stellate ganglion block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06130514, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.