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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06241820
• Other study ID #: 2308-014-1455
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2024
• Est. completion date: April 29, 2024

Study information

• Verified date: February 2024
• Source: Seoul National University Hospital
• Contact: Jeongsoo Kim, MD
• Phone: 821047346422
• Email: dreamsu4[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 29, 2024
• Est. primary completion date: March 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Complex Regional Pain Syndromes
• Neuralgia
• Neuralgia, Postherpetic
• Peripheral Nervous System Diseases
• Peripheral Neuropathy
• Post Herpetic Neuralgia
• Reflex Sympathetic Dystrophy

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Jeongsoo Kim

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (12)

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. — View Citation

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. — View Citation

Day M. Sympathetic blocks: the evidence. Pain Pract. 2008 Mar-Apr;8(2):98-109. doi: 10.1111/j.1533-2500.2008.00177.x. Erratum In: Pain Pract. 2008 Jul-Aug;18(4):335-6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. 2023 Sep 19:rapm-2023-104624. doi: 10.1136/rapm-2023-104624. Online ahead of print. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference of temperature change (°C)	Difference of temperature change (°C) between ipsilateral foot and contralateral foot	before and 1 - 20 minutes after FS-guided lumbar sympathetic ganglion block
Secondary	Severity of pain	11-point Numerical Rating Scale (NRS, 0-10)	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)
Secondary	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	20 minutes after FS-guided lumbar sympathetic ganglion block
Secondary	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	20 minutes after FS-guided lumbar sympathetic ganglion block
Secondary	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	1 - 20 minutes after FS-guided lumbar sympathetic ganglion block
Secondary	Patient satisfaction	Patient Global Impression of Change (1-5)	Time 20 minutes, 1 week, 4 weeks after FS-guided lumbar sympathetic ganglion block (The higher the score, the higher the satisfaction)