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Chronic PainNCT06241820

The Success of Lumbar Sympathetic Ganglion Block Using Lower Extremity Perfusion Index

A study testing Lumbar Sympathetic Ganglion Block in people with Chronic Pain and Complex Regional Pain Syndromes, run by Jeongsoo Kim at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The patient, who is experiencing chronic pain in the lower extremities persisting for more than three months, is scheduled to undergo lumbar sympathetic ganglion block. To evaluate the technical success of the sympathetic blockade, temperature and perfusion index (PI) will be measured at one-minute intervals over a… Read more about this study

Who is it for?
Ages 19 to 85 years
What is being tested?
Lumbar Sympathetic Ganglion Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSouth Korea
Study dates
13 Feb 2024to 30 May 2024
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

  • Lower extremity pain
  • Pain for more than 3 months
  • 19 - 85 years

Who cannot join

  • If the patient refuses to undergo the procedure
  • In the presence of vascular disorders in the lower extremities
  • If the patient has previously undergone lumbar sympathetic ganglion removal or neurolysis
  • When there are abnormalities in blood coagulation tests
  • If there is a systemic infection or infection at the injection site
  • In the presence of anatomical deformities at the injection site
  • If the patient has allergies to the injected medication
  • In other cases where the researcher deems the patient unsuitable for participation

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

Official title: The Success of Lumbar Sympathetic Ganglion Block Using Lower Extremity Perfusion Index: A Prospective Observational Study

The patient, who is experiencing chronic pain in the lower extremities persisting for more than three months, is scheduled to undergo lumbar sympathetic ganglion block. To evaluate the technical success of the sympathetic blockade, temperature and perfusion index (PI) will be measured at one-minute intervals over a 20-minute period before and after the procedure on the treated side and the opposite side foot. Additionally, other variables related to the procedure will be assessed before the procedure, after the procedure, before discharge, and during follow-up outpatient visits or phone surveys at 1 week and 1 month after the procedure.

Read the detailed description

Patients aged 19 to 85 experiencing lower limb pain and scheduled to undergo lumbar sympathetic ganglion block at the Seoul National University Hospital Pain Center will be directly informed about the study, and their participation will be sought and registered. Continuous monitoring of electrocardiography, blood pressure, and pulse oximetry will be conducted before and after the procedure.

Upon admission to the pain center's operating room, the patient will assume a prone position. Thermometers will be attached to the soles of both feet, and perfusion index probes will be attached to the second toe on both sides. Using fluoroscopy guidance, a needle will be inserted at the painful side, either right or left, at the L3. After confirming the needle's position in front of the desired vertebral body using contrast medium in lateral and anteroposterior (AP) views, 7 mL of 0.5% ropivacaine will be injected. Baseline temperature and PI values will be recorded before drug administration, followed by recording every minute for 20 minutes after injection.

Other variables related to the procedure will be assessed before and after the procedure, before discharge, and through outpatient visits or phone surveys at one week after the procedure.

Being tested
Lumbar Sympathetic Ganglion Block
Medical subject headings
Chronic Pain, Complex Regional Pain Syndromes, Peripheral Nervous System Diseases, Neuralgia, Postherpetic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lumbar Sympathetic Ganglion BlockProcedure or surgery

    A needle will be inserted at the L3 on the side experiencing pain, either right or left, under fluoroscopy guidance. Once the needle is positioned in front of the desired vertebral body, its location is confirmed using a contrast medium. If the position is well visualized in lateral and anteroposterior (AP) views, 7 mL of 0.5% ropivacaine will be injected.

Study groups in NCT06241820
Study groupRoleWhat they receive
Lumbar Sympathetic Ganglion Block (LSGB)OtherFS-guided LSGB at L3 level.
Receives: Procedure: Lumbar Sympathetic Ganglion Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference of perfusion index (%)

    Difference of perfusion index (%) between ipsilateral foot and contralateral foot

    Measured: before and 1 - 20 minutes after FS-guided lumbar sympathetic ganglion block

Secondary outcomes (6)

  1. Difference of temperature change (°C)

    Difference of temperature change (°C) between ipsilateral foot and contralateral foot

    Measured: before and 1 - 20 minutes after FS-guided lumbar sympathetic ganglion block

  2. Severity of pain

    11-point Numerical Rating Scale (NRS, 0-10)

    Measured: Time before block and 20 minutes, 1 week, 4 weeks after FS-guided lumbar sympathetic ganglion block ( The higher the score, the more severe the pain)

  3. Proportion of patients reaching ≥ 1.5°C rise

    Proportion of patients reaching ≥ 1.5°C rise of temperature in the ipsilateral foot compared to the contralateral foot

    Measured: 20 minutes after FS-guided lumbar sympathetic ganglion block

  4. Proportion of patients reaching ≥ 2.0°C rise

    Proportion of patients reaching ≥ 2.0°C rise of temperature in the ipsilateral foot compared to initial temperature in the ipsilateral foot

    Measured: 20 minutes after FS-guided lumbar sympathetic ganglion block

  5. Proportion of patients reaching ≥ 100% rise of perfusion index (%)

    Proportion of patients reaching ≥ 100% rise of perfusion index (%) in the ipsilateral foot compared to the initial perfusion index (%) in the ipsilateral foot

    Measured: 1 - 20 minutes after FS-guided lumbar sympathetic ganglion block

  6. Patient satisfaction

    Patient Global Impression of Change (1-5)

    Measured: Time 20 minutes, 1 week, 4 weeks after FS-guided lumbar sympathetic ganglion block (The higher the score, the higher the satisfaction)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2024
  2. Study start13 Feb 2024
  3. Primary completion30 Apr 2024
  4. Study completion30 May 2024

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06241820
Sponsor's protocol ID
2308-014-1455
Status last verified
Jul 2024
First submitted
28 Jan 2024
Last updated
11 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Day M. Sympathetic blocks: the evidence. Pain Pract. 2008 Mar-Apr;8(2):98-109. doi: 10.1111/j.1533-2500.2008.00177.x.

    PubMed 18366465

  • Joo EY, Kong YG, Lee J, Cho HS, Kim SH, Suh JH. Change in pulse transit time in the lower extremity after lumbar sympathetic ganglion block: an early indicator of successful block. J Int Med Res. 2017 Feb;45(1):203-210. doi: 10.1177/0300060516681398. Epub 2017 Jan 17.

    PubMed 28222636

  • Stevens RA, Stotz A, Kao TC, Powar M, Burgess S, Kleinman B. The relative increase in skin temperature after stellate ganglion block is predictive of a complete sympathectomy of the hand. Reg Anesth Pain Med. 1998 May-Jun;23(3):266-70. doi: 10.1016/s1098-7339(98)90053-0.

    PubMed 9613538

  • Kim ED, Yoo WJ, Lee YJ, Park HJ. Perfusion index as a tool to evaluate the efficacy of stellate ganglion block for complex regional pain syndrome. Clin Auton Res. 2019 Apr;29(2):257-259. doi: 10.1007/s10286-018-00585-6. Epub 2019 Jan 1. No abstract available.

    PubMed 30600407

  • Lee JY, Kim ED, Kim YN, Kim JS, Sim WS, Lee HJ, Park HJ, Park HJ. Correlation of Perfusion Index Change and Analgesic Efficacy in Transforaminal Block for Lumbosacral Radicular Pain. J Clin Med. 2019 Jan 7;8(1):51. doi: 10.3390/jcm8010051.

    PubMed 30621004

  • Abdelnasser A, Abdelhamid B, Elsonbaty A, Hasanin A, Rady A. Predicting successful supraclavicular brachial plexus block using pulse oximeter perfusion index. Br J Anaesth. 2017 Aug 1;119(2):276-280. doi: 10.1093/bja/aex166.

    PubMed 28854539

  • Yamazaki H, Nishiyama J, Suzuki T. Use of perfusion index from pulse oximetry to determine efficacy of stellate ganglion block. Local Reg Anesth. 2012;5:9-14. doi: 10.2147/LRA.S30257. Epub 2012 Mar 13.

    PubMed 22915896

  • Ginosar Y, Weiniger CF, Meroz Y, Kurz V, Bdolah-Abram T, Babchenko A, Nitzan M, Davidson EM. Pulse oximeter perfusion index as an early indicator of sympathectomy after epidural anesthesia. Acta Anaesthesiol Scand. 2009 Sep;53(8):1018-26. doi: 10.1111/j.1399-6576.2009.01968.x. Epub 2009 Apr 24.

    PubMed 19397502

  • Huang B, Sun K, Zhu Z, Zhou C, Wu Y, Zhang F, Yan M. Oximetry-derived perfusion index as an early indicator of CT-guided thoracic sympathetic blockade in palmar hyperhidrosis. Clin Radiol. 2013 Dec;68(12):1227-32. doi: 10.1016/j.crad.2013.07.003. Epub 2013 Aug 19.

    PubMed 23969155

  • Cheng J, Salmasi V, You J, Grille M, Yang D, Mascha EJ, Cheng OT, Zhao F, Rosenquist RW. Outcomes of Sympathetic Blocks in the Management of Complex Regional Pain Syndrome: A Retrospective Cohort Study. Anesthesiology. 2019 Oct;131(4):883-893. doi: 10.1097/ALN.0000000000002899.

    PubMed 31365367

  • Samen CDK, Sutton OM, Rice AE, Zaidi MA, Siddarthan IJ, Crimmel SD, Cohen SP. Correlation Between Temperature Rise After Sympathetic Block and Pain Relief in Patients with Complex Regional Pain Syndrome. Pain Med. 2022 Sep 30;23(10):1679-1689. doi: 10.1093/pm/pnac035.

    PubMed 35234922

  • Kim 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 37726196

Questions about this trial

What is this clinical trial studying?

A study testing Lumbar Sympathetic Ganglion Block in people with Chronic Pain and Complex Regional Pain Syndromes, run by Jeongsoo Kim 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 3 inclusion and 8 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 11 Jul 2024. 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?

Difference of perfusion index (%) (time frame: before and 1 - 20 minutes after FS-guided lumbar sympathetic 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 NCT06241820, which also lists 12 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 11 Jul 2024.

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