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

NCT ID: NCT02722096

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2018-03-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Axillary block anesthesia

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

Group Type: EXPERIMENTAL

Axillary block anesthesia with Ropivacaine and Lidocaine

Intervention Type: DRUG

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

Local anesthesia

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

Group Type: ACTIVE_COMPARATOR

Local anesthesia with Ropivacaine and Lidocaine

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Local anesthesia with Ropivacaine and Lidocaine

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas RIMMELE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hopital Edouard Herriot, Hospices Civils de Lyon, France

Locations

Hopital Edouard Herriot - Service Anesthésie et Réanimation

Lyon, , France

Countries

France

References

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

Reference Type: RESULT

Other Identifiers

2013.829

Identifier Type: -

Identifier Source: org_study_id