NCT04439760

Brief Summary

The aim of this study is to assess blood flow velocity in middle cerebral artery measured by transcranial doppler to determine the efficacy of SCG block in decreasing incidence or severity of vasospasm after MCA aneurysm surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

1.6 years

First QC Date

June 13, 2020

Last Update Submit

July 25, 2022

Conditions

Brain AneurysmAneurysm, Ruptured

Keywords

middle cerebral artery

Outcome Measures

Primary Outcomes (1)

  • Change from baseline Blood flow velocity in middle cerebral artery measured by transcranial doppler (TCD)

    Change in Blood flow velocity in patients with ruptured aneurysmal subarachnoid hemorrhage undergoing MCA aneurysmal surgeries measured by transcranial doppler

    The day before surgery (TCD0), Postoperative at day 3 and day 7 (TCD3 & TCD7)

Secondary Outcomes (6)

  • Incidence or severity of MCA postoperative spasm over 14 days.

    within 14 days

  • Change from baseline heart rate

    Baseline (Before surgery) ,after induction the block and at the end of surgery

  • Change from baseline mean arterial blood pressure

    Baseline (Before surgery) ,after induction the block and at the end of surgery

  • Change from baseline oxygen saturation (Sao2)

    Baseline (Before surgery) ,after induction the block and at the end of surgery

  • Incidence of complications (Nerve injury, Hematoma formation, LA toxicity, Sensory or motor deficit, respiratory depression).

    within 14 days

  • +1 more secondary outcomes

Study Arms (2)

control study.

NO INTERVENTION

No intervention

superior cervical block.

ACTIVE COMPARATOR

Under X-ray guidance, a 23-gauge radiofrequency top-pole needle with an active tip of 5 mm is inserted for test blockade. The needle is directed at the facet joint of the 3rd and 4th cervical vertebrae.The needle is introduced parallel to the radiographic projection and is projected as a dot approximately 1 cm anterior to the spine. The radiographic projection is then changed to lateral, and the needle is slowly advanced until the tip was situated at the anterior border of the third cervical vertebra. On the anteroposterior projection, the tip of the needle is projected over the lateral part of the facetal column. When the tip of the needle is in position, 0.3 mL of Omnipaque is injected. On the transverse projection, the contrast is distinctly anterior to anterior border of the vertebral bodies, and in the anteroposterior projection, the contrast is seen spreading in a space overlying the facetal column in a cranial as well as caudal direction.

Procedure: Superior Cervical Ganglion Block

Interventions

Superior Cervical Ganglion BlockPROCEDURE

Under X-ray guidance, a 23-gauge radiofrequency top-pole needle with an active tip of 5 mm is inserted for test blockade. The needle is directed at the facet joint of the 3rd and 4th cervical vertebrae.The needle is introduced parallel to the radiographic projection and is projected as a dot approximately 1 cm anterior to the spine. The radiographic projection is then changed to lateral, and the needle is slowly advanced until the tip was situated at the anterior border of the third cervical vertebra. On the anteroposterior projection, the tip of the needle is projected over the lateral part of the facetal column. When the tip of the needle is in position, 0.3 mL of Omnipaque is injected. On the transverse projection, the contrast is distinctly anterior to anterior border of the vertebral bodies, and in the anteroposterior projection, the contrast is seen spreading in a space overlying the facetal column in a cranial as well as caudal direction.

superior cervical block.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged from 18 to 70 years.
  • Genders eligible for study: both sexes.
  • ASA I-II.
  • GCS (13-15)

You may not qualify if:

  • Patient refusal
  • Contraindications to regional anesthesia (Bleeding disorders, Use of any anti-coagulants, local infection).
  • Known allergy to local anesthetics.
  • ASA III-IV.
  • Patients aged less than 18 or more than 70.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

kasr Al Ainy hospital

Cairo, Egypt

Location

Related Publications (6)

  • Siegenthaler A, Haug M, Eichenberger U, Suter MR, Moriggl B. Block of the superior cervical ganglion, description of a novel ultrasound-guided technique in human cadavers. Pain Med. 2013 May;14(5):646-9. doi: 10.1111/pme.12061. Epub 2013 Feb 25.

    PMID: 23438374BACKGROUND

  • Tuor UI. Local distribution of the effects of sympathetic stimulation on cerebral blood flow in the rat. Brain Res. 1990 Oct 8;529(1-2):224-31. doi: 10.1016/0006-8993(90)90831-u.

    PMID: 2282493BACKGROUND

  • Kurth CD, Wagerle LC, Delivoria-Papadopoulos M. Sympathetic regulation of cerebral blood flow during seizures in newborn lambs. Am J Physiol. 1988 Sep;255(3 Pt 2):H563-8. doi: 10.1152/ajpheart.1988.255.3.H563.

    PMID: 3137827BACKGROUND

  • Koning HM, Dyrbye BA, van Hemert FJ. Percutaneous Radiofrequency Lesion of the Superior Cervical Sympathetic Ganglion in Patients with Tinnitus. Pain Pract. 2016 Nov;16(8):994-1000. doi: 10.1111/papr.12348. Epub 2015 Aug 27.

    PMID: 26311111BACKGROUND

  • Rumalla K, Smith KA, Arnold PM, Mittal MK. Subarachnoid Hemorrhage and Readmissions: National Rates, Causes, Risk Factors, and Outcomes in 16,001 Hospitalized Patients. World Neurosurg. 2018 Feb;110:e100-e111. doi: 10.1016/j.wneu.2017.10.089. Epub 2017 Oct 26.

    PMID: 29107164BACKGROUND

  • Sharma AK, Bathala L, Batra A, Mehndiratta MM, Sharma VK. Transcranial Doppler: Techniques and advanced applications: Part 2. Ann Indian Acad Neurol. 2016 Jan-Mar;19(1):102-7. doi: 10.4103/0972-2327.173407.

    PMID: 27011639BACKGROUND

MeSH Terms

Conditions

Intracranial AneurysmAneurysm, Ruptured

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Officials

  • Fatma Salman, Master

    Kasr El Aini Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
anesthesia assistant lecturer

Study Record Dates

First Submitted

June 13, 2020

First Posted

June 19, 2020

Study Start

October 1, 2020

Primary Completion

May 1, 2022

Study Completion

July 1, 2022

Last Updated

July 26, 2022

Record last verified: 2022-07

Locations

EG(1)