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Stellate Block Versus Nimodipine Infusion for Traumatic Brain Injury

Primary Purpose

Traumatic Brain Injury

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
ultrasound-guided stellate ganglion block
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients more than 18 ys old with isolated head trauma and traumatic brain injury

Exclusion Criteria:

  • • Hemodynamic instability (mean ABP less than 70 mmHg)

    • History of severe systemic disease including cardiopulmonary failure or hepatorenal failure
    • Allergy to local anesthetics
    • Coagulation disorders
    • Abnormal neck structures disturbing normal anatomy as neck tumors

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    ultrasoung guided stellate block

    nimodipine infusion

    Arm Description

    stellate ganglion will have ultrasound-guided block via bupivacaine for sympathectomy and enhancement of cerebral blood flow

    intravenous nimodipine will be given for enhancement of cerebral blood flow

    Outcomes

    Primary Outcome Measures

    enhancement of cerebral blood flow
    increased blood flow through middle cerebral artery and basilar artery measured by transcranial doppler ultraound

    Secondary Outcome Measures

    Full Information

    First Posted
    December 20, 2021
    Last Updated
    December 20, 2021
    Sponsor
    Sohag University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05182619
    Brief Title
    Stellate Block Versus Nimodipine Infusion for Traumatic Brain Injury
    Official Title
    Ultrasound-guided Stellate Ganglion Block Versus Nimodipine Infusion for Enhancement of Cerebral Blood Flow in Traumatic Brain Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2022 (Anticipated)
    Primary Completion Date
    January 1, 2023 (Anticipated)
    Study Completion Date
    April 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sohag University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    the study is designed to perform an intervention for enhancement of cerebral blood flow in patients with traumatic brain injury showing vasospasm through transcranial doppler

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Traumatic Brain Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ultrasoung guided stellate block
    Arm Type
    Active Comparator
    Arm Description
    stellate ganglion will have ultrasound-guided block via bupivacaine for sympathectomy and enhancement of cerebral blood flow
    Arm Title
    nimodipine infusion
    Arm Type
    Active Comparator
    Arm Description
    intravenous nimodipine will be given for enhancement of cerebral blood flow
    Intervention Type
    Procedure
    Intervention Name(s)
    ultrasound-guided stellate ganglion block
    Intervention Description
    under aseptic conditions, using the ultrasound guidance, bilateral stellate ganglion block will be done using bupivacaine and betamethasone mixture, 8 ml volume will be given for each side
    Primary Outcome Measure Information:
    Title
    enhancement of cerebral blood flow
    Description
    increased blood flow through middle cerebral artery and basilar artery measured by transcranial doppler ultraound
    Time Frame
    one week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients more than 18 ys old with isolated head trauma and traumatic brain injury Exclusion Criteria: • Hemodynamic instability (mean ABP less than 70 mmHg) History of severe systemic disease including cardiopulmonary failure or hepatorenal failure Allergy to local anesthetics Coagulation disorders Abnormal neck structures disturbing normal anatomy as neck tumors

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Stellate Block Versus Nimodipine Infusion for Traumatic Brain Injury

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