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

NCT06300658 | Recruiting

• 1 other identifier: 900/2/24
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Fistula flow rate

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

  7th day postoperatively

Secondary Outcomes (4)

• Peak systolic velocity (PSV)

  7th day postoperatively

• End diastolic velocity (EDV)

  7th day postoperatively

• Incidence of failure

  7th day postoperatively

• Adverse effects

  7th day postoperatively

Study Arms (2)

Stellate ganglion blockade

EXPERIMENTAL

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

Drug: Stellate ganglion block

Control group

NO INTERVENTION

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

Interventions

Stellate ganglion block DRUG

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

Stellate ganglion blockade

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 (body mass index \>30 kg/m2).
• Smoking.

Sponsors & Collaborators

• Aswan University: lead

Study Sites (1)

Aswan University

Aswān, Aswan Governorate, 81528, Egypt

RECRUITING

Related Publications (1)

• 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.

  PMID: 40450242 DERIVED

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ayman M Eldemrdash, MD

CONTACT

00201001296116; ayman.mohamady@aswu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Aswan University, Egypt

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 8, 2024
• Study Start: March 9, 2024
• Primary Completion: September 1, 2024
• Study Completion: February 28, 2025
• Last Updated: February 28, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

EG (1)