Clinical Trials Directory

Trials / Completed

CompletedNCT02722096

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
78 (actual)
Sponsor
Hospices Civils de Lyon · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
DRUGAxillary block anesthesia with Ropivacaine and LidocaineAxillary 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 LidocaineLocal subcutaneous infiltration of Ropivacaine and Lidocaine will be performed by anesthetist at the beginning of surgery

Timeline

Start date
2014-03-01
Primary completion
2018-01-26
Completion
2018-03-15
First posted
2016-03-29
Last updated
2025-12-19

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02722096. Inclusion in this directory is not an endorsement.