ClinicalTrials.gg
RecruitingNCT06300658Updated Feb 28, 2025

Stellate Ganglion Block for Preserving Arteriovenous Fistula in Hemodialysis Patients Undergoing Major Lower Limb Orthopedic Surgery

An interventional study of Stellate ganglion block in Stellate Ganglion Block, Arteriovenous Fistula and Hemodialysis, sponsored by Aswan University. Recruiting at 1 site in Egypt. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-28.

Sponsored by Aswan University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 8 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
21 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 11 studies in Arteriovenous Fistula with a site in Egypt — 1 open to participants now, 1 under way, none of them phase 3. Arteriovenous Fistula · Egypt.

Started
2024
with 2 others
No phase
9 of 11
1 open now
Registered
7th of 11
by date
Lead sponsor
1 of 11
Aswan University

Among the 11 studies in Arteriovenous Fistula with a site in Egypt, this one is one of 3 that started in 2024, is one of 9 with no phase, and was the 7th registered.

Arteriovenous Fistula

248 studies on the registry are indexed under Arteriovenous Fistula; 44 are open to participants now.

Browse Arteriovenous Fistula studies →

Open to participants now

1 of the 11 studies in Arteriovenous Fistula with a site in Egypt is open now.

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 27 Arteriovenous Fistula studies recruiting now, 13 (48%) set no upper age limit and 4 (15%) stop at 75 or younger; 3 take children under 18; 2 take healthy volunteers.

This study: 21 Years to 75 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 11 studies in Arteriovenous Fistula with a site in Egypt, or all of them as a file.
02

Study 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 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

03

Conditions studied

  • Stellate Ganglion Block
  • Arteriovenous Fistula
  • Hemodialysis
  • Major Lower Limb Orthopedic Surgery

Browse trials for

04

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 21 to 75 years.
  • Both sexes.
  • (ASA) physical status III.
  • Chronic renal failure (CRF) patients.
  • Undergoing major lower limb orthopedic surgery.

Exclusion criteria

Exclusion Criteria:

  • Psychiatric disorders.
  • History of substance abuse.
  • Ipsilateral brachial and radial artery stenosis.
  • Allergy to local anesthetics.
  • Cardiovascular and respiratory disorders.
  • Coagulopathy.
  • Use of vasoactive medications.
  • Obesity ( >30 kg/m2).
  • Smoking.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Stellate ganglion blockade

    Patient will receive preemptive stellate ganglion blockade (SGB) just before spinal anesthesia.

    Drug: Stellate ganglion block

  • No intervention
    Control group

    Patient will not receive preemptive stellate ganglion blockade (SGB).

Interventions

  • DrugStellate ganglion block

    Patient will receive preemptive stellate ganglion block (SGB) just before spinal anesthesia.

06

What researchers measure

Primary outcomes

  1. Fistula flow rate

    Flow rate will be measured on the first day postoperative then on the 7th day.

    Time frame: 7th day postoperatively

Secondary outcomes

  1. 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.

    Time frame: 7th day postoperatively

  2. 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.

    Time frame: 7th day postoperatively

  3. Incidence of failure

    Incidence of failure will be measured on the first day postoperative then on the 7th day.

    Time frame: 7th day postoperatively

  4. Adverse effects

    Postoperative adverse reactions such as hematoma, infection, thrombosis, bleeding, and pitosis will be recorded in both groups.

    Time frame: 7th day postoperatively

07

Study locations

1 of 1 sites recruiting
  • Aswan University
    Aswan, 81528, Egypt
    Recruiting
    • Ayman M Eldemrdash, MD · Contactayman.mohamady@aswu.edu.eg · 00201001296116
    • Soudy S Hammad, MD · Contact
    • Tarek S Hemaida, MD · Contact
    • Taha T Dardeer, MD · Contact
    • Ahmed A Mohsen, MD · Contact
    • Ahmed K Fathy, MD · Contact
    • Gamal H Shams, MD · Contact
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

Time frame: After the end of study for one year.

Access criteria: The data will be available upon a reasonable request from the corresponding author.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2024 to primary completion in Sep 2024, 5 months.

Of 58 non-industry interventional studies with no phase under Arteriovenous Fistula, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 43. This study's 5 months is below that.

Counting every sponsor, half of 84 studies reached it within 22 months; a quarter within 9 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 29, 2024
First posted
Mar 8, 2024
StartActual
Mar 9, 2024
Primary completionActual
Sep 1, 2024
CompletionEst.
Feb 28, 2025
Last update
Feb 28, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06300658
Lead sponsor
Aswan University
Responsible party
Ayman Mohamady Eldemrdash (Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Aswan University, Egypt, Aswan University) — Principal investigator
First posted
Mar 8, 2024
Start date
Mar 9, 2024
Primary completion
Sep 1, 2024
Completion
Feb 28, 2025 (estimated)
Last update
Feb 28, 2025

Study contacts

Ayman M Eldemrdash, MD
Contact
ayman.mohamady@aswu.edu.eg
00201001296116

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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