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

Primary Purpose

Kidney Failure, Chronic

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Axillary block anesthesia with Ropivacaine and Lidocaine
Local anesthesia with Ropivacaine and Lidocaine
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Kidney Failure, Chronic focused on measuring arteriovenous fistula, regional anesthesia, local anesthesia, early complication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hopital Edouard Herriot - Service Anesthésie et Réanimation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Axillary block anesthesia

Local anesthesia

Arm Description

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

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

Outcomes

Primary Outcome Measures

Rate of early complications related to arteriovenous fistula regardless of type
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

Rate of complications related to arteriovenous fistula regardless of type
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.
Rate of stenosis of arteriovenous fistula
stenosis of arteriovenous fistula : resistance index > 0.6, or peak velocity > 300 cm/s and residual diameter <3 mm
rate of thrombosis
thrombosis: resistance index = 1
incidence of abnormal arteriovenous fistula rate
abnormal arteriovenous fistula rate : lack of maturation (blood flow < 600 ml/min) or high flow (clinical heart failure, blood flow > 1200 ml/min)
incidence of clinical steal syndrome
clinical steal syndrome : trophic or neurological disorders
incidence of arteriovenous fistula infection
incidence of arteriovenous fistula hemorrhage
arteriovenous fistula hemorrhage : spontaneous bleeding, post-puncture bleeding
necessity of radiologic ou surgical reintervention
Rate of stenosis of arteriovenous fistula
stenosis of arteriovenous fistula : resistance index > 0.6, or peak velocity > 300 cm/s and residual diameter <3 mm
rate of thrombosis
thrombosis: resistance index = 1
incidence of abnormal arteriovenous fistula rate
abnormal arteriovenous fistula rate : lack of maturation (blood flow < 600 ml/min) or high flow (clinical heart failure, blood flow > 1200 ml/min)
incidence of clinical steal syndrome
clinical steal syndrome : trophic or neurological disorders
incidence of arteriovenous fistula infection
incidence of arteriovenous fistula hemorrhage
arteriovenous fistula hemorrhage : spontaneous bleeding, post-puncture bleeding
necessity of radiologic ou surgical reintervention

Full Information

First Posted
March 23, 2016
Last Updated
August 27, 2018
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02722096
Brief Title
Creation of Arteriovenous Ante-brachial Fistula Under Axillary Block Versus Local Anesthesia : Impact on Early Complications
Acronym
FAV ss ALR
Official Title
Creation of Arteriovenous Ante-brachial Fistula Under Axillary Block Versus Local Anesthesia : Impact on Early Complications
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
January 26, 2018 (Actual)
Study Completion Date
March 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic
Keywords
arteriovenous fistula, regional anesthesia, local anesthesia, early complication

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Axillary block anesthesia
Arm Type
Experimental
Arm Description
Axillary brachial plexus block anesthesia (with Ropivacaine and Lidocaine) will be performed by anesthetist 30 to 45 minutes before surgery
Arm Title
Local anesthesia
Arm Type
Active Comparator
Arm Description
Local subcutaneous infiltration of Ropivacaine and Lidocaine will be performed by anesthetist at the beginning of surgery
Intervention Type
Drug
Intervention Name(s)
Axillary block anesthesia with Ropivacaine and Lidocaine
Intervention Description
Axillary brachial plexus block anesthesia with injection of Ropivacaine and Lidocaine will be performed by anesthetist 30 to 45 minutes before surgery
Intervention Type
Drug
Intervention Name(s)
Local anesthesia with Ropivacaine and Lidocaine
Intervention Description
Local subcutaneous infiltration of Ropivacaine and Lidocaine will be performed by anesthetist at the beginning of surgery
Primary Outcome Measure Information:
Title
Rate of early complications related to arteriovenous fistula regardless of type
Description
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,
Time Frame
6 weeks after surgery
Secondary Outcome Measure Information:
Title
Rate of complications related to arteriovenous fistula regardless of type
Description
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.
Time Frame
3 months after surgery
Title
Rate of stenosis of arteriovenous fistula
Description
stenosis of arteriovenous fistula : resistance index > 0.6, or peak velocity > 300 cm/s and residual diameter <3 mm
Time Frame
6 weeks after surgery
Title
rate of thrombosis
Description
thrombosis: resistance index = 1
Time Frame
6 weeks after surgery
Title
incidence of abnormal arteriovenous fistula rate
Description
abnormal arteriovenous fistula rate : lack of maturation (blood flow < 600 ml/min) or high flow (clinical heart failure, blood flow > 1200 ml/min)
Time Frame
6 weeks after surgery
Title
incidence of clinical steal syndrome
Description
clinical steal syndrome : trophic or neurological disorders
Time Frame
6 weeks after surgery
Title
incidence of arteriovenous fistula infection
Time Frame
6 weeks after surgery
Title
incidence of arteriovenous fistula hemorrhage
Description
arteriovenous fistula hemorrhage : spontaneous bleeding, post-puncture bleeding
Time Frame
6 weeks after surgery
Title
necessity of radiologic ou surgical reintervention
Time Frame
6 weeks after surgery
Title
Rate of stenosis of arteriovenous fistula
Description
stenosis of arteriovenous fistula : resistance index > 0.6, or peak velocity > 300 cm/s and residual diameter <3 mm
Time Frame
3 months after surgery
Title
rate of thrombosis
Description
thrombosis: resistance index = 1
Time Frame
3 months after surgery
Title
incidence of abnormal arteriovenous fistula rate
Description
abnormal arteriovenous fistula rate : lack of maturation (blood flow < 600 ml/min) or high flow (clinical heart failure, blood flow > 1200 ml/min)
Time Frame
3 months after surgery
Title
incidence of clinical steal syndrome
Description
clinical steal syndrome : trophic or neurological disorders
Time Frame
3 months after surgery
Title
incidence of arteriovenous fistula infection
Time Frame
3 months after surgery
Title
incidence of arteriovenous fistula hemorrhage
Description
arteriovenous fistula hemorrhage : spontaneous bleeding, post-puncture bleeding
Time Frame
3 months after surgery
Title
necessity of radiologic ou surgical reintervention
Time Frame
3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas RIMMELE, MD, PhD
Organizational Affiliation
Hopital Edouard Herriot, Hospices Civils de Lyon, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Edouard Herriot - Service Anesthésie et Réanimation
City
Lyon
ZIP/Postal Code
69437
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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