Creation of Arteriovenous Ante-brachial Fistula Under Axillary Block Versus Local Anesthesia : Impact on Early Complications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Rate of early complications related to arteriovenous fistula regardless of type
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Axillary block anesthesia
Axillary brachial plexus block anesthesia (with Ropivacaine and Lidocaine) will be performed by anesthetist 30 to 45 minutes before surgery
干预措施: Axillary block anesthesia with Ropivacaine and Lidocaine (Drug)
Local anesthesia
Local subcutaneous infiltration of Ropivacaine and Lidocaine will be performed by anesthetist at the beginning of surgery
干预措施: Local anesthesia with Ropivacaine and Lidocaine (Drug)
结局指标
主要结局
Rate of early complications related to arteriovenous fistula regardless of type
时间窗: 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,
次要结局
- incidence of abnormal arteriovenous fistula rate(3 months after surgery)
- incidence of clinical steal syndrome(3 months after surgery)
- incidence of arteriovenous fistula infection(3 months after surgery)
- incidence of arteriovenous fistula hemorrhage(3 months after surgery)
- necessity of radiologic ou surgical reintervention(3 months after surgery)
- Rate of complications related to arteriovenous fistula regardless of type(3 months after surgery)
- Rate of stenosis of arteriovenous fistula(3 months after surgery)
- rate of thrombosis(3 months after surgery)