drugset / Trial / NCT05638620
Dual Sympathetic Blocks for Patients Experiencing Sympathetically-Mediated Symptoms From Long COVID
NaSingle-groupOpen-labelTreatment
Summary
The main purpose of this study is to gather data and assess changes in patient-reported outcomes with the stellate ganglion blocks as treatment for their sympathetically-mediated long COVID symptoms.
Timeline
- Start
- 2023-01-03
- Primary completion
- 2023-06-15
- Completion
- 2023-12-30
Publications
- Background Attal N, Martinez V, Bouhassira D. Potential for increased prevalence of neuropathic pain after the COVID-19 pandemic. Pain Rep. 2021 Jan 27;6(1):e884. doi: 10.1097/PR9.0000000000000884. eCollection 2021 Jan-Feb.
- Background Bucsek MJ, Giridharan T, MacDonald CR, Hylander BL, Repasky EA. An overview of the role of sympathetic regulation of immune responses in infectious disease and autoimmunity. Int J Hyperthermia. 2018 Mar;34(2):135-143. doi: 10.1080/02656736.2017.1411621.
- Background Carmona-Torre F, Minguez-Olaondo A, Lopez-Bravo A, Tijero B, Grozeva V, Walcker M, Azkune-Galparsoro H, Lopez de Munain A, Alcaide AB, Quiroga J, Del Pozo JL, Gomez-Esteban JC. Dysautonomia in COVID-19 Patients: A Narrative Review on Clinical Course, Diagnostic and Therapeutic Strategies. Front Neurol. 2022 May 27;13:886609. doi: 10.3389/fneur.2022.886609. eCollection 2022.
- Background Carod-Artal FJ. Infectious diseases causing autonomic dysfunction. Clin Auton Res. 2018 Feb;28(1):67-81. doi: 10.1007/s10286-017-0452-4. Epub 2017 Jul 20.
- Background Dani M, Dirksen A, Taraborrelli P, Torocastro M, Panagopoulos D, Sutton R, Lim PB. Autonomic dysfunction in 'long COVID': rationale, physiology and management strategies. Clin Med (Lond). 2021 Jan;21(1):e63-e67. doi: 10.7861/clinmed.2020-0896. Epub 2020 Nov 26.
- Background Datta R, Agrawal J, Sharma A, Rathore VS, Datta S. A study of the efficacy of stellate ganglion blocks in complex regional pain syndromes of the upper body. J Anaesthesiol Clin Pharmacol. 2017 Oct-Dec;33(4):534-540. doi: 10.4103/joacp.JOACP_326_16.
- Background Ganesh R, Ghosh AK, Nyman MA, Croghan IT, Grach SL, Anstine CV, Salonen BR, Hurt RT. PROMIS Scales for Assessment of Persistent Post-COVID Symptoms: A Cross Sectional Study. J Prim Care Community Health. 2021 Jan-Dec;12:21501327211030413. doi: 10.1177/21501327211030413.
- Background Goodman BP, Khoury JA, Blair JE, Grill MF. COVID-19 Dysautonomia. Front Neurol. 2021 Apr 13;12:624968. doi: 10.3389/fneur.2021.624968. eCollection 2021.
- Background Grebe KM, Takeda K, Hickman HD, Bailey AL, Embry AC, Bennink JR, Yewdell JW. Cutting edge: Sympathetic nervous system increases proinflammatory cytokines and exacerbates influenza A virus pathogenesis. J Immunol. 2010 Jan 15;184(2):540-4. doi: 10.4049/jimmunol.0903395. Epub 2009 Dec 16.
- Background Kang CK, Oh ST, Chung RK, Lee H, Park CA, Kim YB, Yoo JH, Kim DY, Cho ZH. Effect of stellate ganglion block on the cerebrovascular system: magnetic resonance angiography study. Anesthesiology. 2010 Oct;113(4):936-44. doi: 10.1097/ALN.0b013e3181ec63f5.
- Background Kenney MJ, Ganta CK. Autonomic nervous system and immune system interactions. Compr Physiol. 2014 Jul;4(3):1177-200. doi: 10.1002/cphy.c130051.
- Background Liu LD, Duricka DL. Stellate ganglion block reduces symptoms of Long COVID: A case series. J Neuroimmunol. 2022 Jan 15;362:577784. doi: 10.1016/j.jneuroim.2021.577784. Epub 2021 Dec 8.
- Background Lipov EG, Navaie M, Brown PR, Hickey AH, Stedje-Larsen ET, McLay RN. Stellate ganglion block improves refractory post-traumatic stress disorder and associated memory dysfunction: a case report and systematic literature review. Mil Med. 2013 Feb;178(2):e260-4. doi: 10.7205/MILMED-D-12-00290.
- Background Moon HS, Chon JY, Lee SH, Ju YM, Sung CH. Long-term Results of Stellate Ganglion Block in Patients with Olfactory Dysfunction. Korean J Pain. 2013 Jan;26(1):57-61. doi: 10.3344/kjp.2013.26.1.57. Epub 2013 Jan 4.
- Background Park HM, Kim TW, Choi HG, Yoon KB, Yoon DM. The change in regional cerebral oxygen saturation after stellate ganglion block. Korean J Pain. 2010 Jun;23(2):142-6. doi: 10.3344/kjp.2010.23.2.142. Epub 2010 May 31.
- Background Pongratz G, Straub RH. The sympathetic nervous response in inflammation. Arthritis Res Ther. 2014;16(6):504. doi: 10.1186/s13075-014-0504-2.
- Background Qin Y, Wu J, Chen T, Li J, Zhang G, Wu D, Zhou Y, Zheng N, Cai A, Ning Q, Manyande A, Xu F, Wang J, Zhu W. Long-term microstructure and cerebral blood flow changes in patients recovered from COVID-19 without neurological manifestations. J Clin Invest. 2021 Apr 15;131(8):e147329. doi: 10.1172/JCI147329.
- Background Raveendran AV, Jayadevan R, Sashidharan S. Long COVID: An overview. Diabetes Metab Syndr. 2021 May-Jun;15(3):869-875. doi: 10.1016/j.dsx.2021.04.007. Epub 2021 Apr 20.
- Background Rae Olmsted KL, Bartoszek M, Mulvaney S, McLean B, Turabi A, Young R, Kim E, Vandermaas-Peeler R, Morgan JK, Constantinescu O, Kane S, Nguyen C, Hirsch S, Munoz B, Wallace D, Croxford J, Lynch JH, White R, Walters BB. Effect of Stellate Ganglion Block Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Feb 1;77(2):130-138. doi: 10.1001/jamapsychiatry.2019.3474.
- Background Scala I, Bellavia S, Luigetti M, Brunetti V, Broccolini A, Gabrielli M, Zileri Dal Verme L, Calabresi P, Della Marca G, Frisullo G. Autonomic dysfunction in non-critically ill COVID-19 patients during the acute phase of disease: an observational, cross-sectional study. Neurol Sci. 2022 Aug;43(8):4635-4643. doi: 10.1007/s10072-022-06136-2. Epub 2022 May 24.
- Background Sletten DM, Suarez GA, Low PA, Mandrekar J, Singer W. COMPASS 31: a refined and abbreviated Composite Autonomic Symptom Score. Mayo Clin Proc. 2012 Dec;87(12):1196-201. doi: 10.1016/j.mayocp.2012.10.013.
- Background Tian T, Wu J, Chen T, Li J, Yan S, Zhou Y, Peng X, Li Y, Zheng N, Cai A, Ning Q, Xiang H, Xu F, Qin Y, Zhu W, Wang J. Long-term follow-up of dynamic brain changes in patients recovered from COVID-19 without neurological manifestations. JCI Insight. 2022 Feb 22;7(4):e155827. doi: 10.1172/jci.insight.155827.
- Background Tian Y, Wittwer ED, Kapa S, McLeod CJ, Xiao P, Noseworthy PA, Mulpuru SK, Deshmukh AJ, Lee HC, Ackerman MJ, Asirvatham SJ, Munger TM, Liu XP, Friedman PA, Cha YM. Effective Use of Percutaneous Stellate Ganglion Blockade in Patients With Electrical Storm. Circ Arrhythm Electrophysiol. 2019 Sep;12(9):e007118. doi: 10.1161/CIRCEP.118.007118. Epub 2019 Sep 13.
- Background Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. A classification of chronic pain for ICD-11. Pain. 2015 Jun;156(6):1003-1007. doi: 10.1097/j.pain.0000000000000160. No abstract available.
- Background Umeyama T, Kugimiya T, Ogawa T, Kandori Y, Ishizuka A, Hanaoka K. Changes in cerebral blood flow estimated after stellate ganglion block by single photon emission computed tomography. J Auton Nerv Syst. 1995 Jan 3;50(3):339-46. doi: 10.1016/0165-1838(94)00105-s.
- Background Vallee A. Dysautonomia and Implications for Anosmia in Long COVID-19 Disease. J Clin Med. 2021 Nov 25;10(23):5514. doi: 10.3390/jcm10235514.
- Background Wadehra S. COVID Long Haulers and the New Chronic Pain Profile . Pract Pain Manag. 2022;22(1).
- Background Wulf H, Maier C. [Complications and side effects of stellate ganglion blockade. Results of a questionnaire survey]. Anaesthesist. 1992 Mar;41(3):146-51. German.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Bupivacaine | Other / unclassified | 0.5 % | Other |