NCT04100824

Brief Summary

Aim of work: To evaluate the effect of stellate ganglion block in prevention of cerebrovascular spasm in traumatic subarachnoid hemorrhage Primary outcome: Asses changes of cerebral blood flow velocity by Trans cranial Doppler. Secondary outcome: Asses changes in clinical status

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 11, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2023

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

2.9 years

First QC Date

September 19, 2019

Last Update Submit

June 12, 2023

Conditions

Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • cerebral blood flow velocity

    Asses changes of cerebral blood flow velocity by Trans cranial Doppler

    From 10 minutes to 24 hour after block

Secondary Outcomes (1)

  • clinical status

    Over 10 days

Study Arms (2)

Bupivacaine 0.5%

EXPERIMENTAL

patient will take stellate ganglion block 10 ml bupivacaine 0.5% and nimodipine

Procedure: stellate ganglion block by transcranial dopplerDrug: Nimodipine

Nimodipine

ACTIVE COMPARATOR

patient will take nimodipine 60 mg every 4 h.

Drug: Nimodipine

Interventions

stellate ganglion block by transcranial dopplerPROCEDURE

stellate ganglion block is a block of sympathetic ganglion

Bupivacaine 0.5%
NimodipineDRUG

Nimodipine 60mg every 4h

Bupivacaine 0.5%Nimodipine

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ASA: I, II
  • Head trauma
  • Hemodynamically stable patient
  • Mechanically ventilated or not
  • SAH diagnosed by CT brain

You may not qualify if:

  • relative refusal.
  • allergy to local anesthetic.
  • Any coagulation disorder.
  • Any vascular disease.
  • Penetrating head trauma.
  • Poly traumatized patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ِAssiut University Hospital

Asyut, 1111111, Egypt

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Nimodipine

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNicotinic Acids

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer assistant

Study Record Dates

First Submitted

September 19, 2019

First Posted

September 24, 2019

Study Start

January 11, 2020

Primary Completion

December 11, 2022

Study Completion

January 12, 2023

Last Updated

June 13, 2023

Record last verified: 2023-06

Locations

EG(1)