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

Kidney Failure, Chronic Clinical Trial

— FAV ss ALR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02722096
• Other study ID #: 2013.829
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: March 15, 2018

Study information

• Verified date: August 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: March 15, 2018
• Est. primary completion date: January 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
France	Hopital Edouard Herriot - Service Anesthésie et Réanimation	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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,	6 weeks after surgery
Secondary	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.	3 months after surgery
Secondary	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	6 weeks after surgery
Secondary	rate of thrombosis	thrombosis: resistance index = 1	6 weeks after surgery
Secondary	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)	6 weeks after surgery
Secondary	incidence of clinical steal syndrome	clinical steal syndrome : trophic or neurological disorders	6 weeks after surgery
Secondary	incidence of arteriovenous fistula infection		6 weeks after surgery
Secondary	incidence of arteriovenous fistula hemorrhage	arteriovenous fistula hemorrhage : spontaneous bleeding, post-puncture bleeding	6 weeks after surgery
Secondary	necessity of radiologic ou surgical reintervention		6 weeks after surgery
Secondary	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	3 months after surgery
Secondary	rate of thrombosis	thrombosis: resistance index = 1	3 months after surgery
Secondary	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)	3 months after surgery
Secondary	incidence of clinical steal syndrome	clinical steal syndrome : trophic or neurological disorders	3 months after surgery
Secondary	incidence of arteriovenous fistula infection		3 months after surgery
Secondary	incidence of arteriovenous fistula hemorrhage	arteriovenous fistula hemorrhage : spontaneous bleeding, post-puncture bleeding	3 months after surgery
Secondary	necessity of radiologic ou surgical reintervention		3 months after surgery