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
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
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
NCT ID
NCT02722096
First Posted
March 23, 2016
Last Updated
August 27, 2018
Sponsor
Hospices Civils de Lyon
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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