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

Not Applicable

Completed

Interventions: Drug: Axillary block anesthesia with Ropivacaine and Lidocaine
Drug: Local anesthesia with Ropivacaine and Lidocaine

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

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Axillary block anesthesia	Axillary block anesthesia with Ropivacaine and Lidocaine	Axillary brachial plexus block anesthesia (with Ropivacaine and Lidocaine) will be performed by anesthetist 30 to 45 minutes before surgery
Local anesthesia	Local anesthesia with Ropivacaine and Lidocaine	Local subcutaneous infiltration of Ropivacaine and Lidocaine will be performed by anesthetist at the beginning of surgery

Primary Outcome Measures

Name	Time	Method
Rate of early complications related to arteriovenous fistula regardless of type	6 weeks after surgery	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,

Secondary Outcome Measures

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

Locations (1): Hopital Edouard Herriot - Service Anesthésie et Réanimation
🇫🇷
Lyon, France