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

NCT ID: NCT06241820

Last Updated: 2024-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-13

Study Completion Date

2024-05-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Pain Complex Regional Pain Syndromes Peripheral Neuropathy Post Herpetic Neuralgia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lumbar Sympathetic Ganglion Block (LSGB)

FS-guided LSGB at L3 level.

Group Type OTHER

Lumbar Sympathetic Ganglion Block

Intervention Type 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.

Interventions

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Lumbar Sympathetic Ganglion Block

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jeongsoo Kim

OTHER

Sponsor Role lead

Responsible Party

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Jeongsoo Kim

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jeongsoo Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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

Reference Type BACKGROUND
PMID: 18366465 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28222636 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9613538 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30600407 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30621004 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28854539 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22915896 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19397502 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23969155 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31365367 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35234922 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37726196 (View on PubMed)

Other Identifiers

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2308-014-1455

Identifier Type: -

Identifier Source: org_study_id

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