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

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

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).

Keywords: Cerebral vasospasm; Effectiveness; Prevention; Safety; Stellate ganglion block; Subarachnoid hemorrhage.

Conflict of interest statement

The authors declare no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Study implementation flow chart. The follow-up was completed by a special blinded team, including neurologists, radiologists, nurses, and graduate students. Asterisk symbol (*) indicates that the following time node starts from this moment. Hunt-hess, Hunt and Hess grading; mFisher, modified Fisher grading; GCS, Glasgow Outcome Scale; TCD, transcranial Doppler ultrasound; SGB, stellate ganglion block; HR, heart rate; BP, blood pressure; SpO2, pulse oxygen saturation; PaCO2, arterial partial pressure of carbon dioxide; EtCO2, end-tidal carbon dioxide; T, temperature; UV, urine volume. BIS, bispectral index; ICU, intensive care unit; AEs, adverse events; CAM-ICU, Confusion Assessment Method for the Intensive Care Unit; MMSE, Mini-Mental State Examination; mRS, modified Rankin Scale
Fig. 2
Fig. 2
Schematic diagram of stellate ganglion block under ultrasound guidance. After routine disinfection, 0.5% ropivacaine 8–10 mL will be injected into the surface of the longus colli muscle on the medial side of the prevertebral fascia at the level of the C6 anterior tubercle, and then the puncture point will be covered with sterile dressings. B The ultrasonic image of the cross-section of the sixth cervical segment: the blue arrow indicates the prevertebral fascia; the blue dotted line area is the longus colli muscle, and its lateral highlight area is the distribution of the stellate ganglion; and the green triangle indicates the drug injection site (the inner side of the prevertebral fascia), in which the stellate ganglion can be effectively blocked through the diffusion of the drug solution under the fascia and without nerve injury. C6, the sixth cervical segment; CA, carotid artery; CV, jugular vein; TH, thyroid; at, anterior tubercle; M, muscle; SCM, sternocleidomastoid muscle; LCol, longus colli muscle; LCap, longus capitis muscle; N, nerve from cervical plexus; pt, posterior tubercle. ASM, anterior scalene muscle; MSM, middle scalene muscle

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