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

Not Applicable

Recruiting

• Conditions: Hemodialysis; Arteriovenous Fistula; Stellate Ganglion Block; Major Lower Limb Orthopedic Surgery
• Interventions: Drug: Stellate ganglion block

• Registration Number: NCT06300658
• Lead Sponsor: Aswan University

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.

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 Timeline

• Study First Submitted: 2024-02-29
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-06
• Study First Posted: 2024-03-08
• Study Start: 2024-03-09
• Primary Completion: 2024-09-01
• Last Update Submitted: 2025-02-26
• Study Completion: 2025-02-28
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stellate ganglion blockade	Stellate ganglion block	Patient will receive preemptive stellate ganglion blockade (SGB) just before spinal anesthesia.

Primary Outcome Measures

Name	Time	Method
Fistula flow rate	7th day postoperatively	Flow rate will be measured on the first day postoperative then on the 7th day.

Secondary Outcome Measures

Name	Time	Method
Adverse effects	7th day postoperatively	Postoperative adverse reactions such as hematoma, infection, thrombosis, bleeding, and pitosis will be recorded in both groups.
Peak systolic velocity (PSV)	7th day postoperatively	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.
End diastolic velocity (EDV)	7th day postoperatively	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.
Incidence of failure	7th day postoperatively	Incidence of failure will be measured on the first day postoperative then on the 7th day.

Trial Locations

Locations (1)

Aswan University; 🇪🇬 Aswan, Egypt