Stellate Ganglion Block Using Ultrasound Guidance For Treatment Of Post Clipping Cerebral Vasospasm

NCT02775318 | Completed Phase 1 DMC

• 1 other identifier: NK/1286/DM/1060
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The present study has been designed to assess the efficacy and safety of Stellate Ganglion Block (SGB) in relieving symptomatic cerebral vasospasm following aneurysmal clipping. The effect was assessed by both Digital Subtraction Angiography(DSA) and Transcranial Doppler (TCD).

Conditions

Cerebral Vasospasm

Keywords

Stellate Ganglion; Digital Subtraction Angiography; Transcranial Doppler Ultrasonography

Outcome Measures

Primary Outcomes (3)

• Change in Glasgow Coma Scale from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients

  change in Glasgow Coma Scale from baseline will be assessed a 30 minutes,1 hour, 6,12, 24, 36, 48 hours

• Change in motor power on motor system examination from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients

  change in motor power on motor system examination from baseline will be assessed a 30 minutes,1 hour, 6,12, 24, 36, 48 hours

• Presence or absence of aphasia before and after stellate ganglion block

  it will be assessed at baseline and 30 minutes,1 hour, 6,12, 24, 36, 48 hours after stellate ganglion block

Secondary Outcomes (7)

• Change in Peak systolic velocity on Transcranial doppler from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients

  Parameters will be assessed at Baseline and 30 minutes,1 hour, 6,12, 24, 36, 48 hours after the block

• Change in Mean Flow Velocity on Transcranial Doppler from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients

  Parameters will be assessed at Baseline and 30 minutes,1 hour, 6,12, 24, 36, 48 hours after the block

• Change in LINDEGAARD ratio on Transcranial Doppler from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients

  Parameters will be assessed at Baseline and 30 minutes,1 hour, 6,12, 24, 36, 48 hours after the block

• Change in Pulsatility Index on Transcranial Doppler from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients

  Parameters will be assessed at Baseline and 30 minutes,1 hour, 6,12, 24, 36, 48 hours after the block

• Change in vessel calibre on Digital Subtraction Angiography from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients

  Parameters will be assessed at Baseline and 30 minutes

Study Arms (1)

Stellate Ganglion Block

OTHER

After diagnosis of vasospasm patients were administered ultrasound guided Stellate Ganglion block using 10 cc of 0.5% Inj Bupivacaine on the same side of vasospasm or the side contralateral to the focal neurological deficit.Patients were then assessed using transcranial Doppler and digital subtraction angiography after 30 minutes

Procedure: Stellate Ganglion Block; Drug: Bupivacaine; Procedure: Transcranial Doppler; Procedure: Digital Subtraction Angiography

Interventions

Stellate Ganglion Block PROCEDURE

Under aseptic conditions, transducer is placed on the surface of the neck at the level of C6 vertebrae. The internal jugular vein, carotid artery, thyroid gland, trachea, C6 vertebrae, transverse process of C6, esophagus , longus colli with its covering prevertebral fascia and esophagus are visualized. A 25-gauge Quincke spinal needle was inserted paratracheal towards the middle of the longus colli muscle. The endpoint of the injection was the ultrasound image of the tip of the needle as it penetrates the prevertebral fascia covering the longus colli muscle. The drug is then injected and spread of drug is visualized in real time.

Stellate Ganglion Block

Bupivacaine DRUG

10 ml of 0.5% injection bupivacaine is used for giving stellate ganglion block on the side of cerebral vasospasm

Also known as: Sensorcaine, Marcaine

Stellate Ganglion Block

Transcranial Doppler PROCEDURE

The principle on which the TCD works is that with arterial narrowing, the blood flow velocity within the vessel increases. A good correlation has been found between the TCD blood flow velocities and vasospasm. The MCA velocity greater than 120 cm/sec indicates mild vasospasm , velocity greater than 130 cm/sec indicates moderate vasospasm and velocity greater than 200 cm/sec indicates severe vasospasm.

Stellate Ganglion Block

Digital Subtraction Angiography PROCEDURE

Digital subtraction angiography is a direct method for the assessment of vessel caliber. It generates high resolution, high contrast and low artifact images using digital subtraction technology. Direct visualization using DSA is the gold standard for the radiographic diagnosis of cerebral vasospasm

Also known as: DSA

Stellate Ganglion Block

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient with post aneurysm clipping having symptomatic vasospasm i:e new onset of focal neurological impairment such as hemiparesis, aphasia, apraxia, hemianopia, or neglect or decrease of at least 2 points on the Glasgow Coma Scale (GCS) and duration of symptoms lasting for at least 1 hour.
• Transcranial doppler confirmation of vasospasm by measuring cerebral blood flow velocity in MCA and LINDEGAARD ratio.
• Cerebral angiographic confirmation of the presence of vasospasm by Digital subtraction angiography

You may not qualify if:

• New onset of focal neurological deficit or deterioration in the level of consciousness due to other causes like re-bleeding, hydrocephalus, cerebral edema, electrolyte disorder, infection and seizure.
• Patients having an infarct on cerebral tomography.
• Patients with clipping of more than one aneurysm.
• Patients with bilateral neurological deficits.
• History of allergy to local anaesthetic agents.
• Refusal of consent.
• Deranged coagulation profile.
• Patients with pre-existing pupillary changes where assessment of effectiveness of Stellate ganglion block will be difficult.
• History of allergy to contrast media.
• Derangement of renal parameters

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

MeSH Terms

Conditions

Vasospasm, Intracranial

Interventions

Bupivacaine; Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident In Neuroanesthesia,Department of Anesthesia and Intensive Care

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 17, 2016
• Study Start: September 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 17, 2016

Record last verified: 2016-05