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Post-Traumatic Subarachnoid HemorrhageNCT06134583

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

A study testing Superior cervical sympathetic block group and Stellate ganglion block group in people with Post-Traumatic Subarachnoid Hemorrhage, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Post-Traumatic Subarachnoid Hemorrhage
What is being tested?
Superior cervical sympathetic block group and Stellate ganglion block group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
29 Dec 2023to 14 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 .

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Egypt

    Asyut

Other trials in Egypt

About this study

Official title: Effect of Superior Cervical Sympathetic Block Versus Stellate Ganglion Block to Treat Cerebral Vasospasm in Patients With Refractory Post-traumatic Subarachnoid Hemorrhage.

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.

Read more

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.

Read the detailed description

Trauma patients with CT evidence of post-traumatic SAH will be enrolled in the study and randomly assigned into two groups (30 patients each):

  1. Group A: Superior cervical ganglion block group (CSB); 5 ml bupivacaine 0.5% will be injected around the internal carotid artery at the level of carotid bifurcation on the side of spasm and on each side if bilateral spasm using USG.
  2. Group B: Stellate ganglion block group (SGB); 5 ml bupivacaine 0.5% will be injected between the common carotid artery and longus capitis muscle at the level of C6 vertebra on the side of spasm and on each side if bilateral spasm using USG.

All patients will be treated with a standardized protocol that included immediate intensive care monitoring, hypertension (MABP < 90 mmHg) and avoidance of hypotensive events, fluid resuscitation to maintain hypervolemia (defined as a positive fluid balance >500 mL/d), and spontaneous hemodilution at 0.3 hematocrit. All patients will receive oral nimodipine for 3 weeks. Analgesia as needed and sedation will be avoided if possible.

Intervention Technique:

  1. Superior cervical ganglion block technique;
  • Patients will be placed in the supine position with the head turned to the opposite side of injection.
  • Procedure will be done under complete aseptic technique; mastoid process, hairline, and neck will be disinfected.
  • The common carotid artery will be identified by a high resolution linear ultrasound probe.
  • The probe gradually moved in the cranial direction to the position of the carotid bifurcation.
  • The C2- vertebral transverse process, vertebral artery, longus capitis muscle (LCM), and sternocleidomastoid muscle have been located to determine the puncture route,
  • After injection of a local anesthetic to the skin a needle (25-G injection needle) will be introduced using the in-plane approach, and 5 mL solution of bupivacaine 0.5% will be injected just behind the internal carotid artery.
  • Monitoring during procedure, vital signs (blood pressure, ECG and SPO2) every 10 minutes up to 30 min after block.
  • Endpoints for procedure success are signs of Horner's syndrome will be examined up to 30 min after block.
  • Patients with failed SGB will be excluded.
  1. Stellate ganglion block technique;
  • Patients will be placed in the supine position with the head turned to the opposite side of injection.
  • Procedure will be done under complete aseptic technique; mastoid process, hairline, and neck will be disinfected.
  • The posterior tubercle of C6 vertebrae, vertebral artery will be identified by a high resolution linear ultrasound probe.
  • The probe is moved medially opposite to the level of C6 identifying the common carotid artery, 5 ml solution of bupivacaine 0.5% will be injected between the common carotid and longus colli muscle.
  • The endpoint criterion of SGB success is Horner's syndrome, which is characterized by miosis, ptosis, enophthalmos, conjunctival hyperemia, and facial redness without sweating. The patient will be monitored for at least 30 min to rule out any related complications after SGB.
  • Patients with failed SGB will be excluded.
  1. Basic Transcranial Doppler Exam; A low-frequency ultrasound probe is required (2-3 MHz) due to improved penetration of ultrasound waves through the cranial temporal bones. Both the power M-mode and Doppler mode will be utilized transtemporal window will be used to assess circle of wills arteries.

Transtemporal window:

  1. MCA: Depth of 45-65mm with direction toward the probe.
  2. MCA/ACA bifurcation: Depth of 60-65mm with bidirectional flow.
  3. ACA: Depth of 60-75mm with direction away from the probe.
  4. PCA (P1): Depth of 60-75mm with direction toward the probe.
  5. PCA (P2): Depth of 60-75mm with direction away from the probe.
  6. Terminal ICA: Depth of 60-65mm with direction toward the probe.

Parameters extracted from TCD:

  1. Mean cerebral blood flow velocity: Calculated using peak systolic velocity (PSV) and end-diastolic velocity (EDV) based on the following formula: [PSV + (EDV x 2)]/3[1].
  2. Resistive index: Measure of resistance to blood flow. RI = (PSV - EDV)/PSV[8].
  3. Lindegaard ratio (LR): The LR is a calculated value that normalizes the MCA velocity to the ICA. This is calculated by the mean velocity of the MCA divided by the mean velocity of the ICA. This ratio is important for differentiating hyperemia from true vasospasm on TCD study. If the MCA is increased at a higher proportion than the ICA, it indicates vasospasm as the source of the elevated velocity. A normal LR is considered < 3, mild vasospasm 3.0-4.5, moderate vasospasm 4.5-6.0 and severe vasospasm >6.0.

Pre-interventional Parameters evaluation: -

Standard monitoring includes:

  • Hemodynamics [ECG, Spo2, SBP, DBP and MBP] every 10 minutes during procedure upto 30 minutes after block.
  • Arterial oxygen saturation.
  • Continuous invasive arterial blood pressure monitoring (IABP): systolic arterial blood pressures (SABP), diastolic arterial blood pressure (DABP), mean arterial blood pressure (MABP).
  • Temperature.
  • Preintervention assessment of GCS, CBF by TCD assessment of MCA, ACA and LR ratio and cerebral blood vessels diameter by MRA whenever possible.

Post-interventional data collection: -

  • Duration of study: 24 hours after intervention.
  • Hemodynamics; HR and MBP every 10 minutes up to 2h after block and then every hour.
  • Postintervention reassessment of CBF by TCD assessment of MCA, ACA and LR ratio by the same observer 30 minutes, 6 hours, 24 hours after block.
  • Cerebral blood vessels diameter by MRA within the first 4 hours after block whenever possible.
  • Any change in GCS within one week after block.
Being tested
Superior cervical sympathetic block group, Stellate ganglion block group
Medical subject headings
Subarachnoid Hemorrhage, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Superior cervical sympathetic block groupProcedure or surgery

    Also called CSB

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

  • Stellate ganglion block groupProcedure or surgery

    Also called SGB

    5 ml bupivacaine 0.5% will be injected between the common carotid artery and longus capitis muscle at the level of C6 vertebra

Study groups in NCT06134583
Study groupRoleWhat they receive
Superior cervical ganglion block group (CSB)Active comparatorstandardized protocol + CSB
Receives: Procedure: Superior cervical sympathetic block group
Stellate ganglion block group (SGB)Active comparatorstandardized protocol + SGB
Receives: Procedure: Stellate ganglion block group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. TCD velocities

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

    Measured: 24 hours

Secondary outcomes (3)
  1. New vasospasm

    The incidence of new TCD vasospasm and new CT cerebral infarction.

    Measured: 24 hours

  2. GCS

    Changes in Glasgow Coma Scale (GCS) after block.

    Measured: One week

  3. Technical complications

    Incidence of technical complications.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start29 Dec 2023
  3. Primary completion3 Nov 2025
  4. Study completion14 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Comparison between superior cervical sympathetic block and stellate ganglion block to treat cerebral vasospasm in post-traumatic subarachnoid hemorrhage
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06134583
Sponsor's protocol ID
CSB in SAH
Status last verified
Feb 2026
First submitted
11 Nov 2023
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27309177
  • 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.

    PubMed 34325514
  • 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.

    PubMed 25701099
  • 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.

    PubMed 939973
  • 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.

    PubMed 16381183
  • 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.

    PubMed 21696654
  • 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.

    PubMed 22096287
  • 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.

    PubMed 36597947
  • 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.

    PubMed 37119368
  • 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.

    PubMed 36333751

Questions about this trial

What is this clinical trial studying?

A study testing Superior cervical sympathetic block group and Stellate ganglion block group in people with Post-Traumatic Subarachnoid Hemorrhage, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TCD velocities (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06134583, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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