Creation of Arteriovenous Ante-brachial Fistula Under Axillary Block Versus Local Anesthesia : Impact on Early Complications (FAV ss ALR)

Recommended by the KDOQI vascular access guidelines, antebrachial arteriovenous fistula is the best primary vascular access for hemodialysis in patients with end stage renal disease. The primary complications are common, of the order of 10-36 %, including lack of maturation and dominated by stenosis and thrombosis.

Local anesthesia associated with sedation is a validated method of anesthesia for made arteriovenous fistula but does not cause the motor block and not blocking vasospasm, deleterious to the surgery. Multiple injections necessary to cover the operating zone expose patient to pain and to intravascular injection of local anesthetics.

Regional anesthesia provides better conditions for realize more distal fistula. Sympathetic block provides arterial, venous vasodilation and decreases the incidence of vasospasm . It enables an increased flow rate at an early time fistula and faster maturation.

However, studies included low numbers of patient or are non-randomized. They cannot concluded a significant difference in the complication rate of arteriovenous fistula at an early time depending on the type of anesthesia .

This study aims to demonstrate that axillary block for surgical creation of arteriovenous fistula allows a reduction of complications at 6 weeks compared to local anesthesia

Study Overview

• Status: Completed
• Conditions: Kidney Failure, Chronic
• Intervention / Treatment: Drug: Axillary block anesthesia with Ropivacaine and Lidocaine; Drug: Local anesthesia with Ropivacaine and Lidocaine

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69437
    • Hopital Edouard Herriot - Service Anesthésie et Réanimation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Chronic kidney disease stade 4 or 5
• First creation of arteriovenous fistula on the side of the surgery
• written consent
• Health care system adherent
• No decision of juridical protection

Exclusion Criteria:

• Pregnancy or breast-feeding
• Participation to an other research study that may interfere with this study
• Brachial arterio-venous fistula creation (upper elbow crease)
• Antecedent of homolateral arteriovenous fistula (controlateral fistula non excluded)
• Other surgery on arteriovenous fistula (superficialisation procedure, refection…)
• Contraindications to local anesthetics : Ropivacaine or Lidocaine allergy
• Contraindication to regional anesthesia : homolateral axillary lymphadenectomy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Axillary block anesthesia; Axillary brachial plexus block anesthesia (with Ropivacaine and Lidocaine) will be performed by anesthetist 30 to 45 minutes before surgery	Drug: Axillary block anesthesia with Ropivacaine and Lidocaine; Axillary brachial plexus block anesthesia with injection of Ropivacaine and Lidocaine will be performed by anesthetist 30 to 45 minutes before surgery
Active Comparator: Local anesthesia; Local subcutaneous infiltration of Ropivacaine and Lidocaine will be performed by anesthetist at the beginning of surgery	Drug: Local anesthesia with Ropivacaine and Lidocaine; Local subcutaneous infiltration of Ropivacaine and Lidocaine will be performed by anesthetist at the beginning of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of early complications related to arteriovenous fistula regardless of type	Early complications include stenosis of arteriovenous fistula, thrombosis, lack of maturation, high flow, clinical steal syndrome, arteriovenous fistula infection, arteriovenous fistula hemorrhage, necessity of radiologic ou surgical reintervention,	6 weeks after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of complications related to arteriovenous fistula regardless of type	Complications included stenosis of arteriovenous fistula, thrombosis, lack of maturation, high flow, clinical steal syndrome, arteriovenous fistula infection, arteriovenous fistula hemorrhage, necessity of radiologic ou surgical reintervention.	3 months after surgery
Rate of stenosis of arteriovenous fistula	stenosis of arteriovenous fistula : resistance index > 0.6, or peak velocity > 300 cm/s and residual diameter <3 mm	6 weeks after surgery
rate of thrombosis	thrombosis: resistance index = 1	6 weeks after surgery
incidence of abnormal arteriovenous fistula rate	abnormal arteriovenous fistula rate : lack of maturation (blood flow < 600 ml/min) or high flow (clinical heart failure, blood flow > 1200 ml/min)	6 weeks after surgery
incidence of clinical steal syndrome	clinical steal syndrome : trophic or neurological disorders	6 weeks after surgery
incidence of arteriovenous fistula infection		6 weeks after surgery
incidence of arteriovenous fistula hemorrhage	arteriovenous fistula hemorrhage : spontaneous bleeding, post-puncture bleeding	6 weeks after surgery
necessity of radiologic ou surgical reintervention		6 weeks after surgery
Rate of stenosis of arteriovenous fistula	stenosis of arteriovenous fistula : resistance index > 0.6, or peak velocity > 300 cm/s and residual diameter <3 mm	3 months after surgery
rate of thrombosis	thrombosis: resistance index = 1	3 months after surgery
incidence of abnormal arteriovenous fistula rate	abnormal arteriovenous fistula rate : lack of maturation (blood flow < 600 ml/min) or high flow (clinical heart failure, blood flow > 1200 ml/min)	3 months after surgery
incidence of clinical steal syndrome	clinical steal syndrome : trophic or neurological disorders	3 months after surgery
incidence of arteriovenous fistula infection		3 months after surgery
incidence of arteriovenous fistula hemorrhage	arteriovenous fistula hemorrhage : spontaneous bleeding, post-puncture bleeding	3 months after surgery
necessity of radiologic ou surgical reintervention		3 months after surgery

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Thomas RIMMELE, MD, PhD, Hopital Edouard Herriot, Hospices Civils de Lyon, France

Publications and helpful links

General Publications

• Recommended by the KDOQI vascular access guidelines, antebrachial arteriovenous fistula is the best primary vascular access for hemodialysis in patients with end stage renal disease. The primary complications are common, of the order of 10-36 %, including lack of maturation and dominated by stenosis and thrombosis.~Local anesthesia associated with sedation is a validated method of anesthesia for made arteriovenous fistula but does not cause the motor block and not blocking vasospasm, deleterious to the surgery. Multiple injections necessary to cover the operating zone expose patient to pain and to intravascular injection of local anesthetics.~Regional anesthesia provides better conditions for realize more distal fistula. Sympathetic block provides arterial, venous vasodilation and decreases the incidence of vasospasm . It enables an increased flow rate at an early time fistula and faster maturation.~However, studies included low numbers of patient or are non-randomized. They cannot concluded a significant difference in the complication rate of arteriovenous fistula at an early time depending on the type of anesthesia .~This study aims to demonstrate that axillary block for surgical creation of arteriovenous fistula allows a reduction of complications at 6 weeks compared to local anesthesia

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): January 26, 2018
• Study Completion (Actual): March 15, 2018

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: March 23, 2016
• First Posted (Estimated): March 29, 2016

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: regional anesthesia; local anesthesia; arteriovenous fistula; early complication
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Congenital Abnormalities; Cardiovascular Abnormalities; Renal Insufficiency, Chronic; Vascular Malformations; Fistula; Arteriovenous Malformations; Vascular Fistula; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic; Arteriovenous Fistula; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Anesthesia and Analgesia; Anesthesia, Conduction; Anesthesia; Ropivacaine; Lidocaine; Anesthesia, Local
• Other Study ID Numbers: 2013.829

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO