Cardiac Surgerystellate blockNCT07077824
Effect of Stellate Ganglion Block on Arterial Catheterization Complications in Selected Group of Patients Undergoing Elective Cardiac Surgeries
A study testing Stellate Ganglion Block Injection with Bupivicaine in people with Cardiac Surgery, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Stellate Ganglion Block Injection with Bupivicaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Multiple procedures with expected prolonged bypass time (>100 min)
- EF< 35%
- Moderate or severe Pulmonary hypertension
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
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.
- Conditions
- Cardiac Surgery
- Being tested
- Stellate Ganglion Block Injection with Bupivicaine
- Keywords
- stellate ganglion block, femoral radial gradient, arterial catheterization complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate Ganglion Block Injection with BupivicaineProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Stellate Ganglion Block Injection with Bupivicaine |
| Control group | No intervention | Patients will undergo the surgery according to practised protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of arterial ischemia
Incidence of arterial ischemia in form of colour changes and confirmed by arterial duplex
Measured: from end of surgery till hospital discharge aproximately one week
Secondary outcomes (1)
• Incidence of radial to femoral artery pressure gradient
- 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
Measured: from weaning from cardiopulmonary bypass till transferal to icu aproximately 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start15 Jul 2025
- Primary completion16 May 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, abdallah mahmoud zaki soudi, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077824
- Sponsor's protocol ID
- fmasu R156/2025
- Acronym
- stellate block
- Status last verified
- Oct 2026
- First submitted
- 12 Jul 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stellate Ganglion Block on Arterial Catheterization Complications in Selected Group of Patients Undergoing Elective Cardiac Surgeries
- ClinicalTrials.gov ID
- NCT07077824
- Acronym / sponsor ID
- stellate block / fmasu R156/2025
- Conditions
- Cardiac Surgery
- Keywords
- stellate ganglion block, femoral radial gradient, arterial catheterization complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 16 May 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stellate Ganglion Block group | Experimental | Procedure: Stellate Ganglion Block Injection with BupivicainePatients 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 |
| Control group | No intervention | –Patients will undergo the surgery according to practised protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Multiple procedures with expected prolonged bypass time (>100 min)
Key exclusion criteria (7 listed)
- • Patient not willing to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stellate Ganglion Block Injection with BupivicainePatients 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 or surgery | Stellate Ganglion Block group |
Primary outcome
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
1 secondary outcome
• Incidence of radial to femoral artery pressure gradient
Time frame: from weaning from cardiopulmonary bypass till transferal to icu aproximately 1-2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stellate Ganglion Block Injection with Bupivicaine in people with Cardiac Surgery, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of arterial ischemia (time frame: from end of surgery till hospital discharge aproximately one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.