Stellate Block Versus Nimodipine Infusion for Traumatic Brain Injury

December 20, 2021 updated by: Khaled Mohamed Abdelaal, Sohag University

Ultrasound-guided Stellate Ganglion Block Versus Nimodipine Infusion for Enhancement of Cerebral Blood Flow in Traumatic Brain Injury

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ultrasoung guided stellate block
stellate ganglion will have ultrasound-guided block via bupivacaine for sympathectomy and enhancement of cerebral blood flow
Procedure: ultrasound-guided stellate ganglion block
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
Active Comparator: nimodipine infusion
intravenous nimodipine will be given for enhancement of cerebral blood flow
Procedure: ultrasound-guided stellate ganglion block
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
enhancement of cerebral blood flow
Time Frame: one week
increased blood flow through middle cerebral artery and basilar artery measured by transcranial doppler ultraound
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

December 20, 2021

First Submitted That Met QC Criteria

December 20, 2021

First Posted (Actual)

January 10, 2022

Study Record Updates

Last Update Posted (Actual)

January 10, 2022

Last Update Submitted That Met QC Criteria

December 20, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-Med-21-12-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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