Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202609887557957 Date of Registration: 01/09/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy and Safety of Ultrasound-Guided Stellate Ganglion Block for Cerebral Vasospasm in Traumatic Subarachnoid Hemorrhage.
Official scientific title Efficacy and Safety of Ultrasound-Guided Stellate Ganglion Block for Cerebral Vasospasm in Traumatic Subarachnoid Hemorrhage.
Brief summary describing the background and objectives of the trial Traumatic subarachnoid hemorrhage (tSAH) is a common abnormality following traumatic brain injury that can lead to cerebral vasospasm and secondary brain injury. This study aims to evaluate whether ultrasound-guided stellate ganglion block reduces the incidence of cerebral vasospasm in patients with tSAH compared to standard care.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Injury, Occupational Diseases, Poisoning,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/09/2026
Actual trial start date 01/09/2026
Anticipated date of last follow up 01/09/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ultrasound Guided Stellate Ganglion Block and Nimodipine Infusion SGB: 5–8 mL of 0.5% Bupivacaine. Nimodipine: Intravenous infusion begun at 1 mg/h and later increased to 2 mg/h (intended daily dose of 48 mg). The SGB is a single injection performed within 48 hours of ICU admission. The Nimodipine is administered continuously. Patients will receive an ipsilateral ultrasound-guided stellate ganglion block at the C6 vertebral level using a lateral paratracheal approach. The injectate is deposited anterior to the longus colli fascia. In addition, patients will receive standard care with an intravenous infusion of Nimodipine via a central venous catheter using an electronic syringe pump. 36
Control Group Nimodipine Infusion Standard of Care Intravenous infusion begun at 1 mg/h and later increased to 2 mg/h (intended daily dose of 48 mg). Continuous intravenous infusion. Patients will receive standard care consisting of a continuous intravenous infusion of Nimodipine administered via a central venous catheter. 36 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Both sex. Age from 18 to 65 years old who met the established TCD sonography criteria for exclusion of the definitive diagnosis of CV. a direct sequel of traumatic brain injury (TBI). Hemodynamically stable (MAP ≥65 mmHg with or without vasopressors) Patient refusal. Individuals who had developed cerebral infarction, whether it was directly attributable to CV or secondary to other etiologies. Uncontrolled Psychiatric diseases. Known intolerance to the study drugs. Unstable cardiovascular condition. Patients exhibiting clinical deficits stemming from alternative causes, such as acute or chronic hydrocephalus. Aneurysmal subarachnoid hemorrhage (spontaneous) or other non-traumatic cause Prior cervical surgery, radiation, or anatomical abnormality precluding SGB Known coagulopathy (INR >2.0, platelets <50,000/µL) not correctable before procedure Bilateral tSAH with expected bilateral SGB requirement Active cervical or local infection at injection site Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/06/2026 IRB
Ethics Committee Address
Street address City Postal code Country
Mansoura Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Occurrence of cerebral vasospasm (CV), clinically defined as new focal or global neurological dysfunction and assessed by Transcranial Doppler (TCD). (Note: Your protocol specifically defines this as "where the average MBFV of MCA is ≤ 120 cm/s" Within 7 days following treatment.
Secondary Outcome Neurological outcomes assessed using the Glasgow Outcome Scale (GOS) to categorize overall functional recovery. At the one-month post-intervention timepoint.
Secondary Outcome Neurological disability and dependence assessed using the modified Rankin Scale (mRS). At the one-month post-intervention timepoint.
Secondary Outcome Hemodynamics including blood pressure and heart rate. Continuous daily till 14 days post procedure.
Secondary Outcome Transcranial Doppler (TCD) sonography of the middle cerebral arteries (MCA). Daily till 14 days post procedure.
Secondary Outcome Length of ICU stay, duration of mechanical ventilation, and mortality. 90 day for mortality ICU stay and ventilation measured until discharge.
Secondary Outcome Safety profile and procedure-related adverse events of SGB. Continuous monitoring until clinical stabilization or complete recovery during the entire study period.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university emergency hospital Elgomhoria Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Karim Ali Awad Elgomhoria Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university El Gomhouria Mansoura 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Karim Ali awad Dr.karimali2010@mans.edu.eg 01004209702 El Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of anesthesia
Role Name Email Phone Street address
Public Enquiries Karim Ali awad Dr.karimali2010@mans.edu.eg 01004209702 El Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of anesthesia
Role Name Email Phone Street address
Scientific Enquiries Shimaa Abd El Satar Shalaby shimaashalaby1@gmail.com 01098252796 El Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Deidentified individual participant data (IPD) that underlie the results reported in the final publication will be made available to researchers upon reasonable request to the corresponding author. Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will become available beginning 6 months and ending 36 months following the publication of the study results. Data will be shared with researchers who provide a methodologically sound proposal to achieve aims outlined in the approved proposal. Approval from the local Institutional Research Board (IRB) may be required.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 01/09/2026 PACTR Admin 01 Sep 2026
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 25/08/2026 The reason for the edit was a typographical error. TRUE, IRB, Mansoura, Mansoura, 35516, Egypt, , 13 Jun 2026, 01004209702, Dr.karimali2010@mans.edu.eg, 44938_40266_4737.pdf TRUE, IRB, Mansoura, Mansoura, 35516, Egypt, , 13 June 2026, 01004209702, Dr.karimali2010@mans.edu.eg, 44938_40266_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 25/08/2026 The reason for the edit was a typographical error. TRUE, IRB, Mansoura, Mansoura, 35516, Egypt, , 13 Jun 2026, 01004209702, Dr.karimali2010@mans.edu.eg, 44938_40266_4737.pdf TRUE, IRB, Mansoura, Mansoura, 35516, Egypt, , 13 Jun 2026, +20502202773, irb_staff@mans.edu.eg, 44938_40266_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Maximum age 25/08/2026 The reason for the edit was a typographical error. 65 Year(s) 64 Year(s)