Superior Cervical Sympathetic Block Versus Stellate Ganglion Block in Post-traumatic Subarachnoid Hemorrhage

NCT06134583 | Completed

• 1 other identifier: CSB in SAH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Posttraumatic Subarachnoid hemorrhage (SAH) is a life-threatening neurological problem with a high mortality rate. Delayed cerebral ischemia (DCI) is the second-leading cause of death and disability in patients suffering from SAH. DCI is strongly associated with cerebral arterial vasospasm (CAV), which reduces cerebral blood flow (CBF) and causes cerebral infarction. Various treatment modalities have been tried for the prevention and treatment of vasospasm, including oral nimodipine and isovolumic hypertension, as well as endovascular treatments such as intra-arterial drug infusion and balloon angioplasty. A few studies have demonstrated the role of stellate ganglion block (SGB) in the management of this dreaded complication. Cervical sympathetic block (CSB) may be an effective therapy but is not routinely performed to treat vasospasm/DCI. CSB is a local, minimally invasive, low cost and safe technique that can be performed at the bedside and may offer significant advantages as complementary treatment in combination with more conventional neurointerventional surgery interventions. Aim of study is evaluating the effect of superior sympathetic ganglion block versus stellate ganglion block in treating cerebral vasospasm and prevention of delayed cerebral ischemia in refractory post-traumatic subarachnoid hemorrhage.

Conditions

Post-Traumatic Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

• TCD velocities

  changes in transcranial Doppler (TCD) velocities of middle cerebral artery (MCA) before and after block.

  24 hours

Secondary Outcomes (3)

• New vasospasm

  24 hours

• GCS

  24 hours

• Technical complications

  24 hours

Study Arms (2)

Superior cervical ganglion block group (CSB)

ACTIVE COMPARATOR

standardized protocol + CSB

Procedure: Superior cervical sympathetic block group

Stellate ganglion block group (SGB)

ACTIVE COMPARATOR

standardized protocol + SGB

Procedure: Stellate ganglion block group

Interventions

Stellate ganglion block group PROCEDURE

5 ml bupivacaine 0.5% will be injected between the common carotid artery and longus capitis muscle at the level of C7 vertebra

Also known as: SGB

Stellate ganglion block group (SGB)

Superior cervical sympathetic block group PROCEDURE

5 ml bupivacaine 0.5% will be injected around the internal carotid artery at the level of carotid bifurcation

Also known as: CSB

Superior cervical ganglion block group (CSB)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Trauma patient with radiological evidence of refractory SAH despite adequate pharmacological treatment; TCD velocity \> 120 cm/sec.
• Trauma Patients with clinicoradiological evidence of cerebral vasospasm. The clinical criteria is new onset of neurological impairment such as hemiparesis, aphasia, hemianopia, or decrease of at least 2 points on the GCS not explained by appearance of new finding in follow up CT.
• Age 18-65 will be included in the study
• Both sex are included .

You may not qualify if:

• Refusal to consent participating research from patient or his guardian.
• Patients with deterioration in the level of consciousness due to other causes such as rebleeding, infarct, hydrocephalus, cerebral edema, infection, electrolyte disorder, or seizure.
• Trauma and local infection in the nerve block area.
• Coagulopathy.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Egypt

Asyut, Egypt

Location

Related Publications (10)

• Campos-Pires R, Edge CJ, Dickinson R. Argon: A Noble Foe for Subarachnoid Hemorrhage. Crit Care Med. 2016 Jul;44(7):1456-7. doi: 10.1097/CCM.0000000000001680. No abstract available.

  PMID: 27309177 RESULT

• Dodd WS, Laurent D, Dumont AS, Hasan DM, Jabbour PM, Starke RM, Hosaka K, Polifka AJ, Hoh BL, Chalouhi N. Pathophysiology of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage: A Review. J Am Heart Assoc. 2021 Aug 3;10(15):e021845. doi: 10.1161/JAHA.121.021845. Epub 2021 Jul 30.

  PMID: 34325514 RESULT

• Abboud T, Andresen H, Koeppen J, Czorlich P, Duehrsen L, Stenzig J, Westphal M, Regelsberger J. Serum levels of nimodipine in enteral and parenteral administration in patients with aneurysmal subarachnoid hemorrhage. Acta Neurochir (Wien). 2015 May;157(5):763-7. doi: 10.1007/s00701-015-2369-9. Epub 2015 Feb 21.

  PMID: 25701099 RESULT

• Kosnik EJ, Hunt WE. Postoperative hypertension in the management of patients with intracranial arterial aneurysms. J Neurosurg. 1976 Aug;45(2):148-54. doi: 10.3171/jns.1976.45.2.0148.

  PMID: 939973 RESULT

• Raabe A, Beck J, Keller M, Vatter H, Zimmermann M, Seifert V. Relative importance of hypertension compared with hypervolemia for increasing cerebral oxygenation in patients with cerebral vasospasm after subarachnoid hemorrhage. J Neurosurg. 2005 Dec;103(6):974-81. doi: 10.3171/jns.2005.103.6.0974.

  PMID: 16381183 RESULT

• Cho WS, Kang HS, Kim JE, Kwon OK, Oh CW, Son YJ, Know BJ, Jung C, Hang MH. Intra-arterial nimodipine infusion for cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage. Interv Neuroradiol. 2011 Jun;17(2):169-78. doi: 10.1177/159101991101700205. Epub 2011 Jun 20.

  PMID: 21696654 RESULT

• Jain V, Rath GP, Dash HH, Bithal PK, Chouhan RS, Suri A. Stellate ganglion block for treatment of cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage - A preliminary study. J Anaesthesiol Clin Pharmacol. 2011 Oct;27(4):516-21. doi: 10.4103/0970-9185.86598.

  PMID: 22096287 RESULT

• Bombardieri AM, Albers GW, Rodriguez S, Pileggi M, Steinberg GK, Heit JJ. Percutaneous cervical sympathetic block to treat cerebral vasospasm and delayed cerebral ischemia: a review of the evidence. J Neurointerv Surg. 2023 Dec;15(12):1212-1217. doi: 10.1136/jnis-2022-019838. Epub 2022 Dec 6.

  PMID: 36597947 RESULT

• Maeda A, Chikama Y, Tanaka R, Tominaga M, Shirozu K, Yamaura K. Safety and utility of ultrasound-guided superior cervical ganglion block for headaches and orofacial pain: a retrospective, single-center study of 10 patients. JA Clin Rep. 2023 Apr 29;9(1):21. doi: 10.1186/s40981-023-00613-z.

  PMID: 37119368 RESULT

• Jing L, Wu Y, Liang F, Jian M, Bai Y, Wang Y, Liu H, Wang A, Chen X, Han R. Effect of early stellate ganglion block in cerebral vasospasm after aneurysmal subarachnoid hemorrhage (BLOCK-CVS): study protocol for a randomized controlled trial. Trials. 2022 Nov 4;23(1):922. doi: 10.1186/s13063-022-06867-9.

  PMID: 36333751 RESULT

MeSH Terms

Conditions

Subarachnoid Hemorrhage, Traumatic

Condition Hierarchy (Ancestors)

Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Subarachnoid Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Cerebrovascular Trauma; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Trible masking (participant, care provider and outcomes assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Comparison between superior cervical sympathetic block and stellate ganglion block to treat cerebral vasospasm in post-traumatic subarachnoid hemorrhage

Study Record Dates

• First Submitted: November 11, 2023
• First Posted: November 18, 2023
• Study Start: December 29, 2023
• Primary Completion: November 3, 2025
• Study Completion: November 14, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)