Stellate Ganglion BlockNCT06300658
Stellate Ganglion Block for Preserving Arteriovenous Fistula in Hemodialysis Patients Undergoing Major Lower Limb Orthopedic Surgery
A study testing Stellate ganglion block in people with Stellate Ganglion Block and Arteriovenous Fistula, run by Aswan University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the role of stellate ganglion blockade (SGB) for preserving arteriovenous fistula in hemodialysis patients undergoing major lower limb orthopedic surgery. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Stellate Ganglion Block, Arteriovenous Fistula, Hemodialysis
- What is being tested?
- Stellate ganglion block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Mar 2024to 28 Feb 2025
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 to 75 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status III.
- Chronic renal failure (CRF) patients.
- Undergoing major lower limb orthopedic surgery.
Who cannot join
- Psychiatric disorders.
- History of substance abuse.
- Ipsilateral brachial and radial artery stenosis.
- Allergy to local anesthetics.
- Cardiovascular and respiratory disorders.
- Coagulopathy.
Show all 9Show fewer
- Use of vasoactive medications.
- Obesity (body mass index >30 kg/m2).
- Smoking.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Aswan University
Aswān, Aswan Governorate, 81528
Ayman M Eldemrdash, MD, 00201001296116, ayman.mohamady@aswu.edu.eg
Soudy S Hammad, MD
About this study
Official title: Stellate Ganglion Block for Preserving Arteriovenous Fistula in Hemodialysis Patients Undergoing Major Lower Limb Orthopedic Surgery: A Randomized Controlled Trial
The aim of this study is to evaluate the role of stellate ganglion blockade (SGB) for preserving arteriovenous fistula in hemodialysis patients undergoing major lower limb orthopedic surgery.
Read the detailed description
The best way for dialysis in chronic renal failure (CRF) patients with consideration of feasibility, rate of infection, and patency is hemodialysis by using native access by using arteriovenous fistula (AVF).
Altered calcium and phosphor metabolism in CRF patients would also increase vascular reactivity. Stellate ganglion blockade (SGB) has been used for several years for both diagnosis and treatment of circulatory problems in upper extremity. Recently preemptive SGB has been used in prevention of radial artery spasm in coronary artery patients.
SGB increases blood flow and decrease vascular resistance in the arm. SGB prevents or ameliorates the reactivity of the muscular layer of the RA in response to both surgical manipulation during harvesting the artery and to the potent vasoconstrictor mediators released during surgery
- Conditions
- Stellate Ganglion Block, Arteriovenous Fistula, Hemodialysis, Major Lower Limb Orthopedic Surgery
- Being tested
- Stellate ganglion block
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate ganglion blockDrug
Patient will receive preemptive stellate ganglion block (SGB) just before spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Stellate ganglion blockade | Experimental | Patient will receive preemptive stellate ganglion blockade (SGB) just before spinal anesthesia. Receives: Drug: Stellate ganglion block |
| Control group | No intervention | Patient will not receive preemptive stellate ganglion blockade (SGB). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula flow rate
Flow rate will be measured on the first day postoperative then on the 7th day.
Measured: 7th day postoperatively
Secondary outcomes (4)
Peak systolic velocity (PSV)
Peak systolic velocity (PSV) will be measured from radial artery 2 cm. proximal to fistula site, on the first day postoperative then on the 7th day.
Measured: 7th day postoperatively
End diastolic velocity (EDV)
End diastolic velocity (EDV) will be measured from radial artery 2 cm. proximal to fistula site, on the first day postoperative then on the 7th day.
Measured: 7th day postoperatively
Incidence of failure
Incidence of failure will be measured on the first day postoperative then on the 7th day.
Measured: 7th day postoperatively
Adverse effects
Postoperative adverse reactions such as hematoma, infection, thrombosis, bleeding, and pitosis will be recorded in both groups.
Measured: 7th day postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start9 Mar 2024
- Primary completion1 Sep 2024
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stellate Ganglion BlockStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Mohamady Eldemrdash, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300658
- Sponsor's protocol ID
- 900/2/24
- Status last verified
- Mar 2024
- First submitted
- 29 Feb 2024
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Publications
Eldemrdash AM, Hammad SS, Hemaida TS, Dardeer TT, Mohsen AA, Fathy AK, Shams GH. Stellate ganglion block for preserving arteriovenous fistula in hemodialysis patients undergoing major lower limb orthopedic surgeries: randomized control trial. BMC Anesthesiol. 2025 May 31;25(1):277. doi: 10.1186/s12871-025-03150-7.
PubMed 40450242
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stellate Ganglion Block for Preserving Arteriovenous Fistula in Hemodialysis Patients Undergoing Major Lower Limb Orthopedic Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06300658
- Acronym / sponsor ID
- 900/2/24
- Conditions
- Stellate Ganglion Block, Arteriovenous Fistula, Hemodialysis, Major Lower Limb Orthopedic Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 9 Mar 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 8 Mar 2024 (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.
The aim of this study is to evaluate the role of stellate ganglion blockade (SGB) for preserving arteriovenous fistula in hemodialysis patients undergoing major lower limb orthopedic surgery.
Detailed description
The best way for dialysis in chronic renal failure (CRF) patients with consideration of feasibility, rate of infection, and patency is hemodialysis by using native access by using arteriovenous fistula (AVF).
Altered calcium and phosphor metabolism in CRF patients would also increase vascular reactivity. Stellate ganglion blockade (SGB) has been used for several years for both diagnosis and treatment of circulatory problems in upper extremity. Recently preemptive SGB has been used in prevention of radial artery spasm in coronary artery patients.
SGB increases blood flow and decrease vascular resistance in the arm. SGB prevents or ameliorates the reactivity of the muscular layer of the RA in response to both surgical manipulation during harvesting the artery and to the potent vasoconstrictor mediators released during surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stellate ganglion blockade | Experimental | Drug: Stellate ganglion blockPatient will receive preemptive stellate ganglion blockade (SGB) just before spinal anesthesia. |
| Control group | No intervention | –Patient will not receive preemptive stellate ganglion blockade (SGB). |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 21 to 75 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status III.
- Chronic renal failure (CRF) patients.
- Undergoing major lower limb orthopedic surgery.
Key exclusion criteria (9 listed)
- Psychiatric disorders.
- History of substance abuse.
- Ipsilateral brachial and radial artery stenosis.
- Allergy to local anesthetics.
- Cardiovascular and respiratory disorders.
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 blockPatient will receive preemptive stellate ganglion block (SGB) just before spinal anesthesia. | Drug | Stellate ganglion blockade |
Primary outcome
Fistula flow rate
Time frame: 7th day postoperatively
Flow rate will be measured on the first day postoperative then on the 7th day.
4 secondary outcomes
Peak systolic velocity (PSV)
Time frame: 7th day postoperatively
End diastolic velocity (EDV)
Time frame: 7th day postoperatively
Incidence of failure
Time frame: 7th day postoperatively
Adverse effects
Time frame: 7th day postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Derived from this study: PubMed 40450242Eldemrdash AM, Hammad SS, Hemaida TS, Dardeer TT, Mohsen AA, Fathy AK, Shams GH. Stellate ganglion block for preserving arteriovenous fistula in hemodialysis patients undergoing major lower limb orthopedic surgeries: randomized control trial. BMC Anesthesiol. 2025 May 31;25(1):277. doi: 10.1186/s12871-025-03150-7.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
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 in people with Stellate Ganglion Block and Arteriovenous Fistula, run by Aswan 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Feb 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayman M Eldemrdash, MD (00201001296116, ayman.mohamady@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fistula flow rate (time frame: 7th day postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06300658, which also lists 1 linked publication.
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 Feb 2025.