Pilot study on the influence of anaesthetic choice on prospective outcomes after the creation of an arteriovenous fistula.
Pilot observational study of the influence of anaesthetic choice on arteriovenous fistula failure rate, new peripheral neural symptoms and other comorbidities after the creation of an arteriovenous fistula in patients with end stage renal failure.
Raymond Hu
200 participants
May 20, 2015
Observational
Conditions
Summary
Kidney disease is a significant health issue, with around 2500 new patients requiring treatment every year (Australian data). Around half of these patients will need a surgical connection between their artery and vein (an “arteriovenous fistula” or “AVF”) to facilitate being connected to a machine that functions like a kidney (a haemodialysis machine). There are many methods of providing anaesthesia for the creation of an AVF including a local anaesthetic-based technique to numb the entire limb where the AVF will be created, or a general anaesthesia-based technique where consciousness is lost. It is currently not known whether any particular anaesthetic technique is superior. Theoretical advantages of a local anaesthetic-based technique (also known as a “regional anaesthetic”) include the avoidance of a low blood pressure and better surgical conditions by making the artery and vein larger which may prolong the life of the fistula. On the other hand, potential disadvantages of a regional anaesthetic include the risk of nerve injury. There have been no good quality studies evaluating both these issues, although smaller studies have suggested benefit of a regional anaesthetic technique. The aim of this study is to obtain prospective data from four hospitals regarding the six-week outcomes for patients having their first AVF created under a regional anaesthetic or a general anaesthetic. Patients will be recruited over two years. All four hospitals perform a significant number of regional anaesthetics for this procedure. The main purpose of this study is to determine the number of patients that would be eligible for a future comparative looking at the outcomes of AVF failure and peripheral neural injury; and to determine whether there are appropriate infrastructure mechanisms to collect relevant data for a future comparative trial. Another purpose of this study is to determine the direction of benefit (if any) of using a regional anaesthetic technique over a general anaesthetic technique for this surgery. This data will allow us to assess the feasibility of implementing a future trial where patients will be randomly allocated to receive either a regional anaesthetic or a general anaesthetic for this operation. Determining the impact of anaesthetic technique on six-week outcomes is important as it has the potential to change anaesthetic practice significantly. Reducing the overall complication rate is beneficial to patients with end stage kidney disease. This will facilitate a smooth transition into haemodialysis after initial AVF creation.
Eligibility
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Interventions
Regional anaesthesia technique that is appropriate for the creation of arteriovenous fistula. (Regional anaesthetic technique involves the administration of any local anaesthetic agent to the upper limb brachial plexus for the purpose of anaesthetising the brachial plexus. These blocks include interscalene, supraclavicular, infraclavicullar, axillary blocks or any combination of the above.) The decision to administer a regional anaesthetic is at the discretion of the anaesthetist and surgeon involved. This study is observational only and will not be altering established practice. The surgery itself is expected to take between 30 and 90 minutes. Patients will be followed up prospectively for 6 weeks from the time of surgery.
Locations(8)
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ACTRN12615000393550