Kidney Failure, ChronicFAV ss ALRNCT02722096
Creation of Arteriovenous Ante-brachial Fistula Under Axillary Block Versus Local Anesthesia : Impact on Early Complications
A study testing Axillary block anesthesia with Ropivacaine and Lidocaine and Local anesthesia with Ropivacaine and Lidocaine in people with Kidney Failure, Chronic, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Axillary block anesthesia with Ropivacaine and Lidocaine and Local anesthesia with Ropivacaine and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to 15 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site
Hopital Edouard Herriot - Service Anesthésie et Réanimation
Lyon, 69437
About this study
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.
Read more
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
- Conditions
- Kidney Failure, Chronic
- Being tested
- Axillary block anesthesia with Ropivacaine and Lidocaine, Local anesthesia with Ropivacaine and Lidocaine
- Keywords
- arteriovenous fistula, regional anesthesia, local anesthesia, early complication
- Medical subject headings
- Kidney Failure, Chronic, Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axillary block anesthesia with Ropivacaine and LidocaineDrug
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 LidocaineDrug
Local subcutaneous infiltration of Ropivacaine and Lidocaine will be performed by anesthetist at the beginning of surgery
| Study group | Role | What they receive |
|---|---|---|
| Axillary block anesthesia | Experimental | Axillary brachial plexus block anesthesia (with Ropivacaine and Lidocaine) will be performed by anesthetist 30 to 45 minutes before surgery Receives: Drug: Axillary block anesthesia with Ropivacaine and Lidocaine |
| Local anesthesia | Active comparator | Local subcutaneous infiltration of Ropivacaine and Lidocaine will be performed by anesthetist at the beginning of surgery Receives: Drug: Local anesthesia with Ropivacaine and Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 6 weeks after surgery
Secondary outcomes (15)
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.
Measured: 3 months after surgery
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
Measured: 6 weeks after surgery
rate of thrombosis
thrombosis: resistance index = 1
Measured: 6 weeks after surgery
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)
Measured: 6 weeks after surgery
incidence of clinical steal syndrome
clinical steal syndrome : trophic or neurological disorders
Measured: 6 weeks after surgery
incidence of arteriovenous fistula infection
Measured: 6 weeks after surgery
incidence of arteriovenous fistula hemorrhage
arteriovenous fistula hemorrhage : spontaneous bleeding, post-puncture bleeding
Measured: 6 weeks after surgery
necessity of radiologic ou surgical reintervention
Measured: 6 weeks after surgery
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
Measured: 3 months after surgery
rate of thrombosis
thrombosis: resistance index = 1
Measured: 3 months after surgery
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)
Measured: 3 months after surgery
incidence of clinical steal syndrome
clinical steal syndrome : trophic or neurological disorders
Measured: 3 months after surgery
incidence of arteriovenous fistula infection
Measured: 3 months after surgery
incidence of arteriovenous fistula hemorrhage
arteriovenous fistula hemorrhage : spontaneous bleeding, post-puncture bleeding
Measured: 3 months after surgery
necessity of radiologic ou surgical reintervention
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startMar 2014
- Primary completion26 Jan 2018
- Study completion15 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas RIMMELE, MD, PhD, Principal investigator, Hopital Edouard Herriot, Hospices Civils de Lyon, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722096
- Sponsor's protocol ID
- 2013.829
- Acronym
- FAV ss ALR
- Status last verified
- Dec 2025
- First submitted
- 23 Mar 2016
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of Arteriovenous Ante-brachial Fistula Under Axillary Block Versus Local Anesthesia : Impact on Early Complications
- ClinicalTrials.gov ID
- NCT02722096
- Acronym / sponsor ID
- FAV ss ALR / 2013.829
- Conditions
- Kidney Failure, Chronic
- Keywords
- arteriovenous fistula, regional anesthesia, local anesthesia, early complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- 26 Jan 2018 (actual)
- Study completion
- 15 Mar 2018 (actual)
- First posted
- 29 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axillary block anesthesia | Experimental | Drug: Axillary block anesthesia with Ropivacaine and LidocaineAxillary brachial plexus block anesthesia (with Ropivacaine and Lidocaine) will be performed by anesthetist 30 to 45 minutes before surgery |
| Local anesthesia | Active comparator | Drug: Local anesthesia with Ropivacaine and LidocaineLocal subcutaneous infiltration of Ropivacaine and Lidocaine will be performed by anesthetist at the beginning of surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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…)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axillary block anesthesia with Ropivacaine and LidocaineAxillary brachial plexus block anesthesia with injection of Ropivacaine and Lidocaine will be performed by anesthetist 30 to 45 minutes before surgery | Drug | Axillary block anesthesia |
| Local anesthesia with Ropivacaine and LidocaineLocal subcutaneous infiltration of Ropivacaine and Lidocaine will be performed by anesthetist at the beginning of surgery | Drug | Local anesthesia |
Primary outcome
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,
15 secondary outcomes
Rate of complications related to arteriovenous fistula regardless of type
Time frame: 3 months after surgery
Rate of stenosis of arteriovenous fistula
Time frame: 6 weeks after surgery
rate of thrombosis
Time frame: 6 weeks after surgery
incidence of abnormal arteriovenous fistula rate
Time frame: 6 weeks after surgery
incidence of clinical steal syndrome
Time frame: 6 weeks after surgery
incidence of arteriovenous fistula infection
Time frame: 6 weeks after surgery
incidence of arteriovenous fistula hemorrhage
Time frame: 6 weeks after surgery
necessity of radiologic ou surgical reintervention
Time frame: 6 weeks after surgery
Rate of stenosis of arteriovenous fistula
Time frame: 3 months after surgery
rate of thrombosis
Time frame: 3 months after surgery
incidence of abnormal arteriovenous fistula rate
Time frame: 3 months after surgery
incidence of clinical steal syndrome
Time frame: 3 months after surgery
incidence of arteriovenous fistula infection
Time frame: 3 months after surgery
incidence of arteriovenous fistula hemorrhage
Time frame: 3 months after surgery
necessity of radiologic ou surgical reintervention
Time frame: 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publicationRecommended 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas RIMMELE, MD, PhD principal investigator
Hopital Edouard Herriot, Hospices Civils de Lyon, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axillary block anesthesia with Ropivacaine and Lidocaine and Local anesthesia with Ropivacaine and Lidocaine in people with Kidney Failure, Chronic, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of early complications related to arteriovenous fistula regardless of type (time frame: 6 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02722096, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.