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

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.

Study Overview

• Status: Recruiting
• Conditions: Hemodialysis; Arteriovenous Fistula; Stellate Ganglion Block; Major Lower Limb Orthopedic Surgery
• Intervention / Treatment: Drug: Stellate ganglion block

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayman M Eldemrdash, MD; Phone Number: 00201001296116; Email: ayman.mohamady@aswu.edu.eg

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Recruiting
    • Aswan University
    • Contact: Ayman M Eldemrdash, MD; Phone Number: 00201001296116; Email: ayman.mohamady@aswu.edu.eg
    • Contact: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stellate ganglion blockade; Patient will receive preemptive stellate ganglion blockade (SGB) just before spinal anesthesia.	Drug: Stellate ganglion block; Patient will receive preemptive stellate ganglion block (SGB) just before spinal anesthesia.
No Intervention: Control group; Patient will not receive preemptive stellate ganglion blockade (SGB).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fistula flow rate	Flow rate will be measured on the first day postoperative then on the 7th day.	7th day postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	7th day postoperatively
Incidence of failure	Incidence of failure will be measured on the first day postoperative then on the 7th day.	7th day postoperatively
Adverse effects	Postoperative adverse reactions such as hematoma, infection, thrombosis, bleeding, and pitosis will be recorded in both groups.	7th day postoperatively

Collaborators and Investigators

• Sponsor: Aswan University

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2024
• Primary Completion (Actual): September 1, 2024
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Pathological Conditions, Anatomical; Connective Tissue Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Cysts; Mucinoses; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Ganglion Cysts; Fistula; Arteriovenous Fistula; Synovial Cyst
• Other Study ID Numbers: 900/2/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No