RecruitingACTRN12615000393550

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.


Sponsor

Raymond Hu

Enrollment

200 participants

Start Date

May 20, 2015

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is collecting data on surgical outcomes for patients with end-stage kidney disease who are having a new arteriovenous fistula (AVF) created in their arm — an operation needed before they can start dialysis. The study compares whether patients receive general anaesthesia or a regional nerve block (local anaesthetic that numbs the arm), and tracks outcomes over 6 weeks including whether the fistula is still working and whether any nerve injury occurred. You may be eligible if: - You are 18 years of age or older - You have end-stage kidney failure - You are scheduled to have a new AVF created in your upper limb - You will be receiving either a regional or general anaesthetic for the operation You may NOT be eligible if: - You are pregnant - You are having another operation at the same time on a different part of your body Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 li

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)

Austin Health - Austin Hospital - Heidelberg

VIC, Australia

Box Hill Hospital - Box Hill

VIC, Australia

The Northern Hospital - Epping

VIC, Australia

Barwon Health - Geelong Hospital campus - Geelong

VIC, Australia

Royal Melbourne Hospital - City campus - Parkville

VIC, Australia

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

VIC, Australia

Ballarat Health Services (Base Hospital) - Ballarat Central

VIC, Australia

Bendigo Health Care Group - Bendigo Hospital - Bendigo

VIC, Australia

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ACTRN12615000393550