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

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ClinicalTrials.gov Identifier: NCT02722096
Recruitment Status : Completed
First Posted : March 29, 2016
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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


Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Drug: Axillary block anesthesia with Ropivacaine and Lidocaine Drug: Local anesthesia with Ropivacaine and Lidocaine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Creation of Arteriovenous Ante-brachial Fistula Under Axillary Block Versus Local Anesthesia : Impact on Early Complications
Study Start Date : March 2014
Actual Primary Completion Date : January 26, 2018
Actual Study Completion Date : March 15, 2018

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Arm Intervention/treatment
Experimental: Axillary block anesthesia
Axillary brachial plexus block anesthesia (with Ropivacaine and Lidocaine) will be performed by anesthetist 30 to 45 minutes before surgery
Drug: Axillary block anesthesia with Ropivacaine and Lidocaine
Axillary brachial plexus block anesthesia with injection of Ropivacaine and Lidocaine will be performed by anesthetist 30 to 45 minutes before surgery

Active Comparator: Local anesthesia
Local subcutaneous infiltration of Ropivacaine and Lidocaine will be performed by anesthetist at the beginning of surgery
Drug: Local anesthesia with Ropivacaine and Lidocaine
Local subcutaneous infiltration of Ropivacaine and Lidocaine will be performed by anesthetist at the beginning of surgery




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722096


Locations
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France
Hopital Edouard Herriot - Service Anesthésie et Réanimation
Lyon, France, 69437
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Thomas RIMMELE, MD, PhD Hopital Edouard Herriot, Hospices Civils de Lyon, France

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02722096     History of Changes
Other Study ID Numbers: 2013.829
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hospices Civils de Lyon:
arteriovenous fistula
regional anesthesia
local anesthesia
early complication

Additional relevant MeSH terms:
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Fistula
Renal Insufficiency
Kidney Failure, Chronic
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Anesthetics
Lidocaine
Ropivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action