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

NCT06241820 | Completed

• 1 other identifier: 2308-014-1455
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Chronic Pain; Complex Regional Pain Syndromes; Peripheral Neuropathy; Post Herpetic Neuralgia

Outcome Measures

Primary Outcomes (1)

• Difference of perfusion index (%)

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

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

Secondary Outcomes (6)

• Difference of temperature change (°C)

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

• Severity of pain

  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)

• Proportion of patients reaching ≥ 1.5°C rise

  20 minutes after FS-guided lumbar sympathetic ganglion block

• Proportion of patients reaching ≥ 2.0°C rise

  20 minutes after FS-guided lumbar sympathetic ganglion block

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

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

Study Arms (1)

Lumbar Sympathetic Ganglion Block (LSGB)

OTHER

FS-guided LSGB at L3 level.

Procedure: Lumbar Sympathetic Ganglion Block

Interventions

Lumbar Sympathetic Ganglion Block PROCEDURE

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.

Lumbar Sympathetic Ganglion Block (LSGB)

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lower extremity pain
• Pain for more than 3 months
• years

You may not qualify if:

• 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

Sponsors & Collaborators

• Jeongsoo Kim: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (12)

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

  PMID: 18366465 BACKGROUND

• 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.

  PMID: 28222636 BACKGROUND

• 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.

  PMID: 9613538 BACKGROUND

• 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.

  PMID: 30600407 BACKGROUND

• 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.

  PMID: 30621004 BACKGROUND

• 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.

  PMID: 28854539 BACKGROUND

• 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.

  PMID: 22915896 BACKGROUND

• 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.

  PMID: 19397502 BACKGROUND

• 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.

  PMID: 23969155 BACKGROUND

• 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.

  PMID: 31365367 BACKGROUND

• 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.

  PMID: 35234922 BACKGROUND

• 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.

  PMID: 37726196 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Complex Regional Pain Syndromes; Peripheral Nervous System Diseases; Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neuralgia

Study Officials

• Jeongsoo Kim, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 5, 2024
• Study Start: February 13, 2024
• Primary Completion: April 30, 2024
• Study Completion: May 30, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)