Clinical trial NCT02722096: Creation of Arteriovenous Ante-brachial Fistula Under Axillary Block Versus Local Anesthesia : Impact on Early Complications
Official title: Creation of Arteriovenous Ante-brachial Fistula Under Axillary Block Versus Local Anesthesia : Impact on Early Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure, Chronic
Keywords: arteriovenous fistula
regional anesthesia
local anesthesia
early complication
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-03-29
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


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

Primary outcomes:
measure: Rate of early complications related to arteriovenous fistula regardless of type
timeFrame: 6 weeks after surgery
Secondary outcomes:
measure: Rate of complications related to arteriovenous fistula regardless of type
timeFrame: 3 months after surgery
measure: Rate of stenosis of arteriovenous fistula
timeFrame: 6 weeks after surgery
measure: rate of thrombosis
timeFrame: 6 weeks after surgery
measure: incidence of abnormal arteriovenous fistula rate
timeFrame: 6 weeks after surgery
measure: incidence of clinical steal syndrome
timeFrame: 6 weeks after surgery
measure: incidence of arteriovenous fistula infection
timeFrame: 6 weeks after surgery
measure: incidence of arteriovenous fistula hemorrhage
timeFrame: 6 weeks after surgery
measure: necessity of radiologic ou surgical reintervention
timeFrame: 6 weeks after surgery
measure: Rate of stenosis of arteriovenous fistula
timeFrame: 3 months after surgery
measure: rate of thrombosis
timeFrame: 3 months after surgery
measure: incidence of abnormal arteriovenous fistula rate
timeFrame: 3 months after surgery
measure: incidence of clinical steal syndrome
timeFrame: 3 months after surgery
measure: incidence of arteriovenous fistula infection
timeFrame: 3 months after surgery
measure: incidence of arteriovenous fistula hemorrhage
timeFrame: 3 months after surgery
measure: necessity of radiologic ou surgical reintervention
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Edouard Herriot - Service Anesthésie et Réanimation
Study officials:
affiliation: Hopital Edouard Herriot, Hospices Civils de Lyon, France
name: Thomas RIMMELE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: