Creation of Arteriovenous Ante-brachial Fistula Under Axillary Block Versus Local Anesthesia : Impact on Early Complications

NCT02722096 | Completed

• 1 other identifier: 2013.829
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Kidney Failure, Chronic

Keywords

arteriovenous fistula; regional anesthesia; local anesthesia; early complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Rate of complications related to arteriovenous fistula regardless of type

  3 months after surgery

• Rate of stenosis of arteriovenous fistula

  6 weeks after surgery

• rate of thrombosis

  6 weeks after surgery

• incidence of abnormal arteriovenous fistula rate

  6 weeks after surgery

• incidence of clinical steal syndrome

  6 weeks after surgery

Study Arms (2)

Axillary block anesthesia

EXPERIMENTAL

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

Local anesthesia

ACTIVE COMPARATOR

Local subcutaneous infiltration of Ropivacaine and Lidocaine will be performed by anesthetist at the beginning of surgery

Drug: Local anesthesia with Ropivacaine and Lidocaine

Interventions

Axillary block anesthesia with Ropivacaine and Lidocaine DRUG

Axillary brachial plexus block anesthesia with injection of Ropivacaine and Lidocaine will be performed by anesthetist 30 to 45 minutes before surgery

Axillary block anesthesia

Local anesthesia with Ropivacaine and Lidocaine DRUG

Local subcutaneous infiltration of Ropivacaine and Lidocaine will be performed by anesthetist at the beginning of surgery

Local anesthesia

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hopital Edouard Herriot - Service Anesthésie et Réanimation

Lyon, 69437, France

Location

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic; Arteriovenous Fistula

Interventions

Ropivacaine; Lidocaine; Anesthesia, Local

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Thomas RIMMELE, MD, PhD

  Hopital Edouard Herriot, Hospices Civils de Lyon, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: March 29, 2016
• Study Start: March 1, 2014
• Primary Completion: January 26, 2018
• Study Completion: March 15, 2018
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)