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

Study Overview
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Brief Summary
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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

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

Conditions
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Kidney Failure, Chronic

Intervention / Treatment
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* Drug: Axillary block anesthesia with Ropivacaine and Lidocaine
* Drug: Local anesthesia with Ropivacaine and Lidocaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arteriovenous fistula, regional anesthesia, local anesthesia, early complication