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NCT Number: NCT02722096

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

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

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Key information

Conditions

Kidney Failure, Chronic Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Edouard Herriot - Service Anesthésie et Réanimation

Lyon, 69437, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Axillary block anesthesia with Ropivacaine and Lidocaine

Drug

Axillary brachial plexus block anesthesia with injection of Ropivacaine and Lidocaine will be performed by anesthetist 30 to 45 minutes before surgery

Local anesthesia with Ropivacaine and Lidocaine

Drug

Local subcutaneous infiltration of Ropivacaine and Lidocaine will be performed by anesthetist at the beginning of surgery

Primary outcomes

  1. Rate of early complications related to arteriovenous fistula regardless of type

    Time frame: 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 outcomes

  1. Rate of complications related to arteriovenous fistula regardless of type

    Time frame: 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.

  2. Rate of stenosis of arteriovenous fistula

    Time frame: 6 weeks after surgery

    stenosis of arteriovenous fistula : resistance index > 0.6, or peak velocity > 300 cm/s and residual diameter <3 mm

  3. rate of thrombosis

    Time frame: 6 weeks after surgery

    thrombosis: resistance index = 1

  4. incidence of abnormal arteriovenous fistula rate

    Time frame: 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)

  5. incidence of clinical steal syndrome

    Time frame: 6 weeks after surgery

    clinical steal syndrome : trophic or neurological disorders

  6. incidence of arteriovenous fistula infection

    Time frame: 6 weeks after surgery

  7. incidence of arteriovenous fistula hemorrhage

    Time frame: 6 weeks after surgery

    arteriovenous fistula hemorrhage : spontaneous bleeding, post-puncture bleeding

  8. necessity of radiologic ou surgical reintervention

    Time frame: 6 weeks after surgery

  9. Rate of stenosis of arteriovenous fistula

    Time frame: 3 months after surgery

    stenosis of arteriovenous fistula : resistance index > 0.6, or peak velocity > 300 cm/s and residual diameter <3 mm

  10. rate of thrombosis

    Time frame: 3 months after surgery

    thrombosis: resistance index = 1

  11. incidence of abnormal arteriovenous fistula rate

    Time frame: 3 months 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)

  12. incidence of clinical steal syndrome

    Time frame: 3 months after surgery

    clinical steal syndrome : trophic or neurological disorders

  13. incidence of arteriovenous fistula infection

    Time frame: 3 months after surgery

  14. incidence of arteriovenous fistula hemorrhage

    Time frame: 3 months after surgery

    arteriovenous fistula hemorrhage : spontaneous bleeding, post-puncture bleeding

  15. necessity of radiologic ou surgical reintervention

    Time frame: 3 months after surgery

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: FAV ss ALR

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 29, 2016
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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