Complex Regional Pain SyndromesNCT04876989
The Comparison of Sympathetic Blockade of Stellate Ganglion Block and Thoracic Paravertebral Block
A study testing US-SGB and US-TPVB in people with Complex Regional Pain Syndromes and Postherpetic Neuralgia, run by Seoul National University at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Complex Regional Pain Syndromes, Postherpetic Neuralgia, Phantom Limb Pain
- What is being tested?
- US-SGB and US-TPVB
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Jul 2021to 16 Jan 2023
- 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
- 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
Who cannot join
- 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.)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
Well-trained pain physicians performs all US-guided stellate ganglion block(SGB)s or US-guided thoracic paravertebrl block(TPVB)s, who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure.
For US-guided SGB, patients are supine positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at C6 level. 5 ml of 1% mepivacaine is injected for the SGB group. Syringes are prepared by one nurse who do not involved in other steps of this study.
For US-guided TPVB, patients are prone positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at T2 paravertebral space. 10 ml of 1% mepivacaine is injected for the TPVB group. Syringes are prepared by one nurse who do not involved in other steps of this study.
Temperature measurement is conducted 2 times (before US-guided SGB or TPVB and after 20 minutes) at both hands by one person who's not involved in other measuring in the study.
- Conditions
- Complex Regional Pain Syndromes, Postherpetic Neuralgia, Phantom Limb Pain, Chronic Post Surgical Pain, Post-Traumatic Neuralgia, Neuropathic Pain
- Being tested
- US-SGB, US-TPVB
- Medical subject headings
- Complex Regional Pain Syndromes, Neuralgia, Postherpetic, Phantom Limb, Pain, Postoperative, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US-SGBProcedure or surgery
Well trained pain physician performs all the ultrasound(US)-guided stellate ganglion block(SGB)s, who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure. For US-guided SGB, patients are supine positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at C6 level. 5 ml of 1% mepivacaine is injected for the US-SGB group.
US-TPVBProcedure or surgery
Well trained pain physician performs all the ultrasound(US)-guided thoracic paravertebral block(SGB)s, who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure. For US-guided TPVB, patients are prone positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at T2 paravertebral space. 10 ml of 1% mepivacaine is injected for the US-TPVB group.
| Study group | Role | What they receive |
|---|---|---|
| US-SGB | Active comparator | 5 ml of 1% mepivacaine is injected for stellate ganglion block using the Ultrasound(US)-guided lateral approach at the sixth cervical vertebral level. Receives: Procedure: US-SGB |
| US-TPVB | Active comparator | 10 ml of 1% mepivacaine is injected for thoracic paravertebral block using the Ultrasound(US)-guided sagittal approach at the second thoracic paravertebral space. Receives: Procedure: US-TPVB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block
Secondary outcomes (5)
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.
Measured: 20 minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block
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.
Measured: Time before block and 20 minutes and 1 week and 4weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block
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.
Measured: Time 20 minutes and 1 week and 4 weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block
Comparison of Korean version CISS(Cold Intolerance Symptom Severity) Questionnaire
Check the CISS before the procedure and 4 weeks after the procedure.
Measured: Time before block and 4 weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block
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.
Measured: Time before block and 20minutes after US-guided thoracic paravertebral 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 posted7 May 2021
- Study start21 Jul 2021
- Primary completion19 Dec 2022
- Study completion16 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain SyndromesStudies 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
- Participant
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University
- Sponsor type
- University, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Principal investigator, Jeeyoun Moon, Seoul National University
- Investigators
- Youn Moon Jee, MD, PhD, Study director, Seoul National University HospitalJeongsoo Kim, MD, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876989
- Sponsor's protocol ID
- 2102-183-120
- Status last verified
- Oct 2023
- First submitted
- 3 May 2021
- Last updated
- 17 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. 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 Paravertebral Block in Patients With Chronic Upper Extremity Neuropathic Pain: a Prospective Randomized and Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT04876989
- Acronym / sponsor ID
- 2102-183-120
- Conditions
- Complex Regional Pain Syndromes, Postherpetic Neuralgia, Phantom Limb Pain, Chronic Post Surgical Pain, Post-Traumatic Neuralgia, Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Seoul National UniversityUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 16 Jan 2023 (actual)
- First posted
- 7 May 2021 (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.
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.
Detailed description
Well-trained pain physicians performs all US-guided stellate ganglion block(SGB)s or US-guided thoracic paravertebrl block(TPVB)s, who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure.
For US-guided SGB, patients are supine positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at C6 level. 5 ml of 1% mepivacaine is injected for the SGB group. Syringes are prepared by one nurse who do not involved in other steps of this study.
For US-guided TPVB, patients are prone positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at T2 paravertebral space. 10 ml of 1% mepivacaine is injected for the TPVB group. Syringes are prepared by one nurse who do not involved in other steps of this study.
Temperature measurement is conducted 2 times (before US-guided SGB or TPVB and after 20 minutes) at both hands by one person who's not involved in other measuring in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US-SGB | Active comparator | Procedure: US-SGB5 ml of 1% mepivacaine is injected for stellate ganglion block using the Ultrasound(US)-guided lateral approach at the sixth cervical vertebral level. |
| US-TPVB | Active comparator | Procedure: US-TPVB10 ml of 1% mepivacaine is injected for thoracic paravertebral block using the Ultrasound(US)-guided sagittal approach at the second thoracic paravertebral space. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| US-SGBWell trained pain physician performs all the ultrasound(US)-guided stellate ganglion block(SGB)s, who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure. For US-guided SGB, patients are supine positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at C6 level. 5 ml of 1% mepivacaine is injected for the US-SGB group. | Procedure or surgery | US-SGB |
| US-TPVBWell trained pain physician performs all the ultrasound(US)-guided thoracic paravertebral block(SGB)s, who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure. For US-guided TPVB, patients are prone positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at T2 paravertebral space. 10 ml of 1% mepivacaine is injected for the US-TPVB group. | Procedure or surgery | US-TPVB |
Primary outcome
Proportion of patients reaching > 1.5°C rise of temperature in the ipsilateral hand compared to the contralateral hand
Time frame: 20 minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block
Temperature is measured with a laser thermometer on the palmar aspect of 3 cm below from the middle finger.
5 secondary outcomes
Difference of temperature change (°C) between ipsilateral hand and contralateral hand
Time frame: 20 minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block
Severity of pain
Time frame: Time before block and 20 minutes and 1 week and 4weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block
Patient global impression change (PGIC)
Time frame: Time 20 minutes and 1 week and 4 weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block
Comparison of Korean version CISS(Cold Intolerance Symptom Severity) Questionnaire
Time frame: Time before block and 4 weeks after US-guided thoracic paravertebral block or US-guided stellate ganglion block
Blood flow velocity measurement in upper extremity vessel(ipsilateral brachial artery) using ultrasound
Time frame: Time before block and 20minutes after US-guided thoracic paravertebral block or US-guided stellate ganglion block
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Youn Moon Jee, MD, PhD study director
Seoul National University Hospital
Jeongsoo Kim, MD principal investigator
SMG-SNU Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing US-SGB and US-TPVB in people with Complex Regional Pain Syndromes and Postherpetic Neuralgia, run by Seoul National University at 1 site in South Korea.
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 7 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: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients reaching > 1.5°C rise of temperature in the ipsilateral hand compared to the contralateral hand (time frame: 20 minutes after US-guided thoracic paravertebral 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?
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 17 Oct 2023.