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Open Access 01-12-2022 | Subarachnoid Hemorrhage | Study protocol

Effect of early stellate ganglion block in cerebral vasospasm after aneurysmal subarachnoid hemorrhage (BLOCK-CVS): study protocol for a randomized controlled trial

Authors: Longnian Jing, Youxuan Wu, Fa Liang, Minyu Jian, Yang Bai, Yunzhen Wang, Haiyang Liu, Anxin Wang, Xiaolin Chen, Ruquan Han

Published in: Trials | Issue 1/2022

Abstract

Introduction

Stellate ganglion block has been reported to expand cerebral vessels and alleviate vasospasm after aneurysmal subarachnoid hemorrhage. However, the causal relationship between early stellate ganglion block and cerebral vasospasm prevention has not yet been established. The purpose of this study was to explore the effectiveness and safety of early stellate ganglion block as a preventive treatment for cerebral vasospasm and delayed cerebral ischemia.

Methods/design

This is a single-center, prospective, randomized, controlled, blinded endpoint assessment superiority trial. A total of 228 patients will be randomized within 48 h of aneurysmal subarachnoid hemorrhage onset in a 1:1 ratio into two groups, one group receiving an additional e-SGB and the other group receiving only a camouflaging action before anesthesia induction in the operating room. The primary outcome is the incidence of symptomatic vasospasm within 14 days after aSAH. Further safety and efficacy parameters include the incidence of radiographic vasospasm, new cerebral infarction, postoperative delirium, and complications up to 90 days after surgery; postoperative cerebral hemodynamics; Mini-Mental State Examination score; modified Rankin scale score; and all-cause mortality up to 90 days after surgery.

Discussion

This is a randomized controlled trial to explore the effectiveness and safety of early stellate ganglion block as a preventive treatment to reduce cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage. If the results are positive, it may provide a new direction for the prevention and treatment of cerebral vasospasm and delayed cerebral ischemia.

Trial registration

The study was registered on Clincaltrials.gov on December 13, 2020 (NCT04691271).

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D’Souza S. Aneurysmal subarachnoid hemorrhage. J Neurosurg Anesthesiol. 2015;27(3):222–40. https://doi.org/10.1097/ANA.0000000000000130.CrossRefPubMedPubMedCentral

Neifert SN, Chapman EK, Martini ML, Shuman WH, Schupper AJ, Oermann EK, et al. Aneurysmal subarachnoid hemorrhage: the last decade. Transl Stroke Res. 2021;12(3):428–46. https://doi.org/10.1007/s12975-020-00867-0.CrossRefPubMed

Veldeman M, Höllig A, Clusmann H, Stevanovic A, Rossaint R, Coburn M. Delayed cerebral ischaemia prevention and treatment after aneurysmal subarachnoid haemorrhage: a systematic review. Brit J Anaesth. 2016;117(1):17–40. https://doi.org/10.1093/bja/aew095.CrossRefPubMedPubMedCentral

Rouanet C, Silva GS. Aneurysmal subarachnoid hemorrhage: current concepts and updates. Arq Neuro-Psiquiat. 2019;77(11):806–14. https://doi.org/10.1590/0004-282X20190112.CrossRef

Connolly ES, Rabinstein AA, Carhuapoma JR, Derdeyn CP, Dion J, Higashida RT, et al. Guidelines for the management of aneurysmal subarachnoid hemorrhage. Stroke. 2012;43(6):1711–37. https://doi.org/10.1161/STR.0b013e3182587839.CrossRefPubMed

Cho WS, Kim JE, Park SQ, Ko JK, Kim DW, Park JC, et al. Korean clinical practice guidelines for aneurysmal subarachnoid hemorrhage. J Korean Neurosurg Soc. 2018;61(2):127–66. https://doi.org/10.3340/jkns.2017.0404.005.CrossRefPubMedPubMedCentral

Solter VV, Roje-Bedekovic M, Breitenfeld T, Supanc V, Lovrencic-Huzjan A, Seric V, et al. Recommendations for the management of medical complications in patients following aneurysmal subarachnoid hemorrhage. Acta Clin Croat. 2014;53(1):113–38.PubMed

Burns SK, Brewer KJ, Jenkins C, Miller S. Aneurysmal subarachnoid hemorrhage and vasospasm. AACN Adv Crit Care. 2018;29(2):163–74. https://doi.org/10.4037/aacnacc2018491.CrossRefPubMed

Khey K, Huard A, Mahmoud SH. Inflammatory pathways following subarachnoid hemorrhage. Cell Mol Neurobiol. 2020;40(5):675–93. https://doi.org/10.1007/s10571-019-00767-4.CrossRefPubMed

10.

Zhang Z, Fang Y, Lenahan C, Chen S. The role of immune inflammation in aneurysmal subarachnoid hemorrhage. Exp Neurol. 2021;336: 113535. https://doi.org/10.1016/j.expneurol.2020.113535.CrossRef

11.

Zheng VZ, Wong GKC. Neuroinflammation responses after subarachnoid hemorrhage: a review. J Clin Neurosci. 2017;42:7–11. https://doi.org/10.1016/j.jocn.2017.02.001.CrossRefPubMed

12.

Suzuki H, Fujimoto M, Kawakita F, Liu L, Nakano F, Nishikawa H, et al. Toll-like receptor 4 and tenascin-C signaling in cerebral vasospasm and brain injuries after subarachnoid hemorrhage. Acta Neurochir Suppl. 2020;127:91–6. https://doi.org/10.1007/978-3-030-04615-6_15.CrossRefPubMed

13.

Carlson AP, Hänggi D, Macdonald RL, Shuttleworth CW. Nimodipine reappraised: an old drug with a future. Curr Neuropharmacol. 2020;18(1):65–82. https://doi.org/10.2174/1570159X17666190927113021.CrossRefPubMedPubMedCentral

14.

Dawley T, Claus CF, Tong D, Rajamand S, Sigler D, Bahoura M, et al. Efficacy and safety of cilostazol-nimodipine combined therapy on delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage: a prospective, randomised, double-blinded, placebo-controlled trial protocol. BMJ Open. 2020;10(10):e036217. https://doi.org/10.1136/bmjopen-2019-036217.CrossRefPubMedPubMedCentral

15.

Veldeman M, Hollig A, Clusmann H, Stevanovic A, Rossaint R, Coburn M. Delayed cerebral ischaemia prevention and treatment after aneurysmal subarachnoid haemorrhage: a systematic review. Br J Anaesth. 2016;117(1):17–40. https://doi.org/10.1093/bja/aew095.CrossRefPubMedPubMedCentral

16.

Charpentier C, Audibert G, Guillemin F, Civit T, Ducrocq X, Bracard S, et al. Multivariate analysis of predictors of cerebral vasospasm occurrence after aneurysmal subarachnoid hemorrhage. Stroke. 1999;30(7):1402–8. https://doi.org/10.1161/01.str.30.7.1402.CrossRefPubMed

17.

Shan T, Zhang T, Qian W, Ma L, Li B, You C, et al. Effectiveness and feasibility of cilostazol in patients with aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis. J Neurol. 2020;267(6):1577–84. https://doi.org/10.1007/s00415-019-09198-z.CrossRefPubMed

18.

Shen J, Shen J, Zhu K, Zhou H, Tian H, Yu G. Efficacy of statins in cerebral vasospasm, mortality, and delayed cerebral ischemia in patients with aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis of randomized controlled trials. World Neurosurg. 2019;131:e65–73. https://doi.org/10.1016/j.wneu.2019.07.016.CrossRefPubMed

19.

Kumar G, Shahripour RB, Harrigan MR. Vasospasm on transcranial Doppler is predictive of delayed cerebral ischemia in aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis. J Neurosurg. 2016;124(5):1257–64. https://doi.org/10.3171/2015.4.JNS15428.CrossRefPubMed

20.

Bederson JB, Connolly EJ, Batjer HH, Dacey RG, Dion JE, Michael ND, et al. Guidelines for the management of aneurysmal subarachnoid hemorrhage: a statement for healthcare professionals from a special writing group of the Stroke Council. American Heart Association Stroke. 2009;40(3):994–1025. https://doi.org/10.1161/STROKEAHA.108.191395.CrossRefPubMed

21.

Kenney MJ, Ganta CK. Autonomic nervous system and immune system interactions. Compr Physiol. 2014;4(3):1177–200. https://doi.org/10.1002/cphy.c130051.CrossRefPubMedPubMedCentral

22.

Li TT, Wan Q, Zhang X, Xiao Y, Sun LY, Zhang YR, et al. Stellate ganglion block reduces inflammation and improves neurological function in diabetic rats during ischemic stroke. Neural Regen Res. 2022;17(9):1991–7. https://doi.org/10.4103/1673-5374.335162.CrossRefPubMedPubMedCentral

23.

Hu N, Wu Y, Chen B, Han J, Zhou M. Protective effect of stellate ganglion block on delayed cerebral vasospasm in an experimental rat model of subarachnoid hemorrhage. Brain Res. 2014;1585:63–71. https://doi.org/10.1016/j.brainres.2014.08.012.CrossRefPubMed

24.

Chen Y, Guo L, Lang H, Hu X, Jing S, Luo M, et al. Effect of a stellate ganglion block on acute lung injury in septic rats. Inflammation. 2018;41(5):1601–9. https://doi.org/10.1007/s10753-018-0803-x.CrossRefPubMed

25.

Lipov E, Gluncic V, Lukic IK, Candido K. How does stellate ganglion block alleviate immunologically-linked disorders? Med Hypotheses. 2020;144:110000. https://doi.org/10.1016/j.mehy.2020.110000.CrossRefPubMed

26.

Zhang J, Nie Y, Pang Q, Zhang X, Wang Q, Tang J. Effects of stellate ganglion block on early brain injury in patients with subarachnoid hemorrhage: a randomised control trial. Bmc Anesthesiol. 2021;21(1):23. https://doi.org/10.1186/s12871-020-01215-3.CrossRefPubMedPubMedCentral

27.

Zhao HY, Yang GT, Sun NN, Kong Y, Liu YF. Efficacy and safety of stellate ganglion block in chronic ulcerative colitis. World J Gastroenterol. 2017;23(3):533–9. https://doi.org/10.3748/wjg.v23.i3.533.CrossRefPubMedPubMedCentral

28.

Gupta MM, Bithal PK, Dash HH, Chaturvedi A, Mahajan RP. Effects of stellate ganglion block on cerebral haemodynamics as assessed by transcranial Doppler ultrasonography. Brit J Anaesth. 2005;95(5):669–73. https://doi.org/10.1093/bja/aei230.CrossRefPubMed

29.

Treggiari MM, Romand J, Martin J, Reverdin A, Rüfenacht DA, Tribolet ND. Cervical sympathetic block to reverse delayed ischemic neurological deficits after aneurysmal subarachnoid hemorrhage. Stroke. 2003;34(4):961–7. https://doi.org/10.1161/01.STR.0000060893.72098.80.CrossRefPubMed

30.

Dash H, Chouhan R, Jain V, Rath G, Bithal P, Suri A. Stellate ganglion block for treatment of cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage - a preliminary study. J Anaesthesiol Clin Pharmacol. 2011;27(4):516. https://doi.org/10.4103/0970-9185.86598.CrossRefPubMedPubMedCentral

31.

Wendel C, Scheibe R, Wagner S, Tangemann W, Henkes H, Ganslandt O, et al. Decrease of blood flow velocity in the middle cerebral artery after stellate ganglion block following aneurysmal subarachnoid hemorrhage: a potential vasospasm treatment? J Neurosurg. 2020;133:773–9. https://doi.org/10.3171/2019.5.JNS182890.CrossRef

32.

Doi S, Cho N, Obara T. Stellate ganglion block increases blood flow in the anastomotic artery after superficial temporal artery–middle cerebral artery bypass. Brit J Anaesth. 2016;117(3):395–6. https://doi.org/10.1093/bja/aew230.CrossRefPubMed

33.

Pileggi M, Mosimann PJ, Isalberti M, Piechowiak EI, Merlani P, Reinert M, et al. Stellate ganglion block combined with intra-arterial treatment: a “one-stop shop” for cerebral vasospasm after aneurysmal subarachnoid hemorrhage-a pilot study. Neuroradiology. 2021;63(10):1701–8. https://doi.org/10.1007/s00234-021-02689-9.CrossRefPubMed

34.

Frontera JA, Fernandez A, Schmidt JM, Claassen J, Wartenberg KE, Badjatia N, et al. Defining vasospasm after subarachnoid hemorrhage: what is the most clinically relevant definition? Stroke. 2009;40(6):1963–8. https://doi.org/10.1161/STROKEAHA.108.544700.CrossRefPubMed

35.

Suwatcharangkoon S, De Marchis GM, Witsch J, Meyers E, Velazquez A, Falo C, et al. Medical treatment failure for symptomatic vasospasm after subarachnoid hemorrhage threatens long-term outcome. Stroke. 2019;50(7):1696–702. https://doi.org/10.1161/STROKEAHA.118.022536.CrossRefPubMed

36.

McGirt MJ, Garces AG, Huang J, Tamargo RJ. Simvastatin for the prevention of symptomatic cerebral vasospasm following aneurysmal subarachnoid hemorrhage: a single-institution prospective cohort study. J Neurosurg. 2009;110(5):968–74. https://doi.org/10.3171/2008.10.JNS08901.CrossRefPubMed

37.

Rae OK, Bartoszek M, Mulvaney S, Mclean B, Turabi A, Young R, et al. Effect of stellate ganglion block treatment on posttraumatic stress disorder symptoms: a randomized clinical trial. Jama Psychiat. 2020;77(2):130–8. https://doi.org/10.1001/jamapsychiatry.2019.3474.CrossRef

38.

Muhammad S, Hanggi D. Inflammation and anti-inflammatory targets after aneurysmal subarachnoid hemorrhage. Int J Mol Sci. 2021;22(14):7355. https://doi.org/10.3390/ijms22147355.CrossRefPubMedPubMedCentral

39.

Nassiri F, Ibrahim GM, Badhiwala JH, Witiw CD, Mansouri A, Alotaibi NM, et al. A propensity score-matched study of the use of non-steroidal anti-inflammatory agents following aneurysmal subarachnoid hemorrhage. Neurocrit Care. 2016;25(3):351–8. https://doi.org/10.1007/s12028-016-0266-6.CrossRefPubMed

40.

Solar P, Mackerle Z, Joukal M, Jancalek R. Non-steroidal anti-inflammatory drugs in the pathophysiology of vasospasms and delayed cerebral ischemia following subarachnoid hemorrhage: a critical review. Neurosurg Rev. 2021;44(2):649–58. https://doi.org/10.1007/s10143-020-01276-5.CrossRefPubMed

41.

Celik O, Bilginer B, Korkmaz A, Gurgor PN, Bavbek M, Ozgen T, et al. Effects of intramuscular parecoxib administration on vasospasm in an experimental subarachnoid hemorrhage model. Int J Neurosci. 2011;121(6):316–22. https://doi.org/10.3109/00207454.2011.556284.CrossRefPubMed

42.

Yokoyama M, Nakatsuka H, Itano Y, Hirakawa M. Stellate ganglion block modifies the distribution of lymphocyte subsets and natural-killer cell activity. Anesthesiology. 2000;92(1):109–15. https://doi.org/10.1097/00000542-200001000-00021.CrossRefPubMed

43.

Sugimoto M, Shimaoka M, Taenaka N, Kiyono H, Yoshiya I. Lymphocyte activation is attenuated by stellate ganglion block. Reg Anesth Pain Med. 1999;24(1):30–5. https://doi.org/10.1016/s1098-7339(99)90162-1.CrossRefPubMed

44.

Yang X, Shi Z, Li X, Li J. Impacts of stellate ganglion block on plasma NF-kappaB and inflammatory factors of TBI patients. Int J Clin Exp Med. 2015;8(9):15630–8.PubMedPubMedCentral

Title: Effect of early stellate ganglion block in cerebral vasospasm after aneurysmal subarachnoid hemorrhage (BLOCK-CVS): study protocol for a randomized controlled trial
Authors: Longnian Jing
Youxuan Wu
Fa Liang
Minyu Jian
Yang Bai
Yunzhen Wang
Haiyang Liu
Anxin Wang
Xiaolin Chen
Ruquan Han
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Subarachnoid Hemorrhage
Subarachnoid Hemorrhage
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06867-9

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Effect of early stellate ganglion block in cerebral vasospasm after aneurysmal subarachnoid hemorrhage (BLOCK-CVS): study protocol for a randomized controlled trial

Abstract

Introduction

Methods/design

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Introduction

Methods/design

Discussion

Trial registration

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