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

Hemodialysis Clinical Trial

Official title:

Stellate Ganglion Block for Preserving Arteriovenous Fistula in Hemodialysis Patients Undergoing Major Lower Limb Orthopedic Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06300658
• Other study ID #: 900/2/24
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: March 2024
• Source: Aswan University
• Contact: Ayman M Eldemrdash, MD
• Phone: 00201001296116
• Email: ayman.mohamady[@]aswu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula
• Ganglion Cysts
• Hemodialysis
• Stellate Ganglion Block

Intervention

Drug:
• Stellate ganglion block
Patient will receive preemptive stellate ganglion block (SGB) just before spinal anesthesia.

Locations

Country	Name	City	State
Egypt	Aswan University	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fistula flow rate	Flow rate will be measured on the first day postoperative then on the 7th day.	7th day postoperatively
Secondary	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
Secondary	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
Secondary	Incidence of failure	Incidence of failure will be measured on the first day postoperative then on the 7th day.	7th day postoperatively
Secondary	Adverse effects	Postoperative adverse reactions such as hematoma, infection, thrombosis, bleeding, and pitosis will be recorded in both groups.	7th day postoperatively