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

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ClinicalTrials.gov Identifier: NCT02775318
Recruitment Status : Completed
First Posted : May 17, 2016
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):
NAVNEH SAMAGH, Postgraduate Institute of Medical Education and Research

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).

Condition or disease Intervention/treatment Phase
Cerebral Vasospasm Procedure: Stellate Ganglion Block Drug: Bupivacaine Procedure: Transcranial Doppler Procedure: Digital Subtraction Angiography Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy Of Ultrasound Guided Stellate Ganglion Block To Relieve Vasospasm Following Clipping Of Cerebral Aneurysm
Study Start Date : September 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Stellate Ganglion Block
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
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.

Drug: Bupivacaine
10 ml of 0.5% injection bupivacaine is used for giving stellate ganglion block on the side of cerebral vasospasm
Other Names:
  • Sensorcaine
  • Marcaine

Procedure: Transcranial Doppler
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.

Procedure: Digital Subtraction Angiography
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
Other Name: DSA




Primary Outcome Measures :
  1. Change in Glasgow Coma Scale from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients [ Time Frame: change in Glasgow Coma Scale from baseline will be assessed a 30 minutes,1 hour, 6,12, 24, 36, 48 hours ]
  2. Change in motor power on motor system examination from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients [ Time Frame: change in motor power on motor system examination from baseline will be assessed a 30 minutes,1 hour, 6,12, 24, 36, 48 hours ]
  3. Presence or absence of aphasia before and after stellate ganglion block [ Time Frame: it will be assessed at baseline and 30 minutes,1 hour, 6,12, 24, 36, 48 hours after stellate ganglion block ]

Secondary Outcome Measures :
  1. Change in Peak systolic velocity on Transcranial doppler from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients [ Time Frame: Parameters will be assessed at Baseline and 30 minutes,1 hour, 6,12, 24, 36, 48 hours after the block ]
  2. Change in Mean Flow Velocity on Transcranial Doppler from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients [ Time Frame: Parameters will be assessed at Baseline and 30 minutes,1 hour, 6,12, 24, 36, 48 hours after the block ]
  3. Change in LINDEGAARD ratio on Transcranial Doppler from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients [ Time Frame: Parameters will be assessed at Baseline and 30 minutes,1 hour, 6,12, 24, 36, 48 hours after the block ]
  4. Change in Pulsatility Index on Transcranial Doppler from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients [ Time Frame: Parameters will be assessed at Baseline and 30 minutes,1 hour, 6,12, 24, 36, 48 hours after the block ]
  5. Change in vessel calibre on Digital Subtraction Angiography from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients [ Time Frame: Parameters will be assessed at Baseline and 30 minutes ]
  6. Change in parenchymal filling time on Digital Subtraction Angiography from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients [ Time Frame: Parameters will be assessed at Baseline and 30 minutes ]
  7. Change in Venous sinus filling time on Digital Subtraction Angiography from baseline that will occur after giving stellate ganglion block in post clipping cerebral vasospasm patients [ Time Frame: Parameters will be assessed at Baseline and 30 minutes ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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Responsible Party: NAVNEH SAMAGH, Senior Resident In Neuroanesthesia,Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT02775318     History of Changes
Other Study ID Numbers: NK/1286/DM/1060
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by NAVNEH SAMAGH, Postgraduate Institute of Medical Education and Research:
Stellate Ganglion
Digital Subtraction Angiography
Transcranial Doppler Ultrasonography

Additional relevant MeSH terms:
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Ganglion Cysts
Vasospasm, Intracranial
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents