Creation of Arteriovenous Ante-brachial Fistula Under Axillary Block Versus Local Anesthesia : Impact on Early Complications (FAV ss ALR)

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Civil Hospices of Lyon

Status

Completed

Conditions

Kidney Failure, Chronic

Treatments

Drug: Axillary block anesthesia with Ropivacaine and Lidocaine
Drug: Local anesthesia with Ropivacaine and Lidocaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02722096
2013.829

Details and patient eligibility

About

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

Enrollment

78 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

78 participants in 2 patient groups

Axillary block anesthesia
Experimental group
Description:
Axillary brachial plexus block anesthesia (with Ropivacaine and Lidocaine) will be performed by anesthetist 30 to 45 minutes before surgery
Treatment:
Drug: Axillary block anesthesia with Ropivacaine and Lidocaine
Local anesthesia
Active Comparator group
Description:
Local subcutaneous infiltration of Ropivacaine and Lidocaine will be performed by anesthetist at the beginning of surgery
Treatment:
Drug: Local anesthesia with Ropivacaine and Lidocaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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