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NCT Number: NCT07077824

Effect of Stellate Ganglion Block on Arterial Catheterization Complications in Selected Group of Patients Undergoing Elective Cardiac Surgeries

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of medicine Ain Shams University

Cairo, 02, Egypt

Location status: Recruiting

Location contact

abdallah soudi

CONTACT

[email protected]

01111228925

About this study

Invasive blood monitoring is an essential prerequisite in all cardiac surgeries where the radial artery is the most common one used. It is easily accessible, apart from important nerves and has a well-known safe profile.

As perfection is an unattainable dream, radial artery complications do happen ranging from spasm, occlusion, hematoma formation and dissection Although incidence of ischemia post radial artery occlusion is not as common as the occlusion, serious effects do happen as reported digital necrosis and the need to do below elbow amputation in one case Patients undergoing cardiac surgeries usually suffers from many risk factors for Ischemic complications as risk of hypotension and use of vasoconstrictors The use of vasoconstrictors is more expected in patients with preoperative decreased Left Ventricle (LV) function (≤30%), moderate to severe Pulmonary Hypertension (PH), multiple procedures and prolonged bypass time.

Also, a complication that is relatively common in open heart surgeries is the central to radial artery pressure gradient that is usually encountered post bypass and may last for some time after and may affect up to 45% of patients in cardiac surgeries.

Usually the pressure gradient is for favor of the radial artery in awake patients due to the vascular resistance, but many theories tried to explain the cause of the opposed gradient post bypass. One theory related the issue to Vasoconstriction of the brachial artery.

Over the last few years, there were some studies, which investigated the effect of regional anesthesia techniques such as thoracic epidural anesthesia (TEA) and stellate ganglion block (SGB) for sympatholysis in cardiac surgeries The SGB with local anesthetics have been widely used to provide pain relief to treat vascular spastic disorders of upper limbs, chronic pain conditions and treatment of refractory angina The SGB has also been used for increasing radial artery (RA) blood flow and preventing RA spasm by sympathetic blockade in coronary artery bypass surgery In the current study, SGB will be studied regarding its effect in minimizing the occurrence of complications related to arterial catheterization in selected patients in cardiac surgeries.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • • 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

Treatment and study plan

Stellate Ganglion Block Injection with Bupivicaine

Procedure

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

Primary outcomes

  1. Incidence of arterial ischemia

    Time frame: from end of surgery till hospital discharge aproximately one week

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

Secondary outcomes

  1. • Incidence of radial to femoral artery pressure gradient

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

    • Incidence of radial to femoral artery pressure gradient which is defined as one of the following: >25 mmhg in systolic BP or > 10 mmhg in mean BP that is sustained for > 5 minutes either before, on or after CPB

Study contacts

Contact information is provided by the study sponsor or research team.

abdallah M soudi

CONTACT

[email protected]

+201111228925

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Acronym: stellate block

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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