NCT07077824

Brief Summary

Radial artery catheterization is the usual method for invasive monitoring in cardiac surgeries. Although it is relatively safe, complications do happen. Hematoma and ischemia are well known complications. Also, radial-to-femoral arterial pressure gradient (RFAPG) post bypass is a common event which affect management of a critical patient in a critical time. the study examines the effect of left stellate ganglion block (LSGB) on decreasing radial artery complications in cardiac surgeries

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

July 12, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

July 15, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

July 12, 2025

Last Update Submit

July 12, 2025

Conditions

Keywords

stellate ganglion blockfemoral radial gradientarterial catheterization complications

Outcome Measures

Primary Outcomes (1)

  • Incidence of arterial ischemia

    Incidence of arterial ischemia in form of colour changes and confirmed by arterial duplex

    from end of surgery till hospital discharge aproximately one week

Secondary Outcomes (1)

  • • Incidence of radial to femoral artery pressure gradient

    from weaning from cardiopulmonary bypass till transferal to icu aproximately 1-2 hours

Study Arms (2)

Stellate Ganglion Block group

EXPERIMENTAL

Patients will receive left stellate ganglion block US guided after induction of anesthesia and intubation and after insertion of Rt IJV CVL and before skin incision

Procedure: Stellate Ganglion Block Injection with Bupivicaine

Control group

NO INTERVENTION

Patients will undergo the surgery according to practised protocol

Interventions

Patients will receive left stellate ganglion block US guided after induction of anesthesia and intubation and after insertion of Rt IJV CVL and before skin incision

Stellate Ganglion Block group

Eligibility Criteria

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

You may qualify if:

  • Multiple procedures with expected prolonged bypass time (\>100 min)
  • EF\< 35%
  • Moderate or severe Pulmonary hypertension

You may not qualify if:

  • Patient not willing to participate in the study.
  • History of strokes / Transient ischaemic attacks
  • History of Glaucoma.
  • History of allergy to local anaesthetic drugs.
  • Pre-existing contralateral phrenic nerve palsy.
  • Patients with existing coagulopathy.
  • BMI \>35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of medicine Ain Shams University

Cairo, 02, Egypt

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 12, 2025

First Posted

July 22, 2025

Study Start

July 15, 2025

Primary Completion

January 16, 2026

Study Completion

March 1, 2026

Last Updated

July 22, 2025

Record last verified: 2025-07

Locations