Kidney Failure, Chronic
Conditions
Keywords
arteriovenous fistula, regional anesthesia, local anesthesia, early complication
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
Interventions
DRUGAxillary 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
DRUGLocal anesthesia with Ropivacaine and Lidocaine
Local subcutaneous infiltration of Ropivacaine and Lidocaine will be performed by anesthetist at the beginning of surgery
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of stenosis of arteriovenous fistula | 6 weeks after surgery | stenosis of arteriovenous fistula : resistance index \> 0.6, or peak velocity \> 300 cm/s and residual diameter \<3 mm |
| rate of thrombosis | 6 weeks after surgery | thrombosis: resistance index = 1 |
| incidence of abnormal arteriovenous fistula rate | 6 weeks 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) |
| 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. |
| incidence of arteriovenous fistula infection | 6 weeks after surgery | — |
| incidence of arteriovenous fistula hemorrhage | 6 weeks after surgery | arteriovenous fistula hemorrhage : spontaneous bleeding, post-puncture bleeding |
| necessity of radiologic ou surgical reintervention | 6 weeks after surgery | — |
| incidence of clinical steal syndrome | 6 weeks after surgery | clinical steal syndrome : trophic or neurological disorders |
Countries
France
Outcome results
None listed