Title: Anaesthesia Choice for Creation of ArtEriovenous FiStulae (ACCESs study)_x000D_ _x000D_ A randomised controlled trial comparing clinical (one-year functional patency rate) and cost-effectiveness of regional versus local anaesthesia for primary arteriovenous fistula formation
Funder: Chief Scientist Office, Scotland

Abstract: Many patients with kidney failure require dialysis to remove toxins from the bloodstream. During dialysis blood from the patient is taken into the dialysis machine, cleaned and then returned back to the patient. This requires entry and exit ‘access’ points into patients’ blood vessels. The best form of access is called a fistula (an artificial connection between the artery and vein made with a small operation in the arm)._x000D_ _x000D_ Unfortunately, fistula creation is not an exact science. Up to half fail within a year of being created. The reason why fistulas fail and how we can prevent it are largely unknown._x000D_ _x000D_ The fistula operation can be performed under local anaesthetic (i.e. injection of anaesthetic into the wrist or elbow to numb the area where the surgeon will operate) or anaesthetic ‘block’ (i.e. injection of anaesthetic around the nerves in the neck to numb the entire arm for many hours). It might be that the ‘block’ also improves blood flow to the arm. Theoretically this could improve the success of a fistula operation but we are not sure. Currently in the UK there is no agreement on what to do and each unit chooses based on local preference and resources._x000D_ _x000D_ Our study aims to compare the success of fistulas created under local anaesthesia versus an anaesthetic ‘block’._x000D_ Patients requiring fistula creation will be randomised (like tossing a coin) to have their fistula made under local anaesthetic or ‘block’. After the surgery most patients will be able to go home on the same day. They will be reviewed twice afterwards (3 and 12 months following surgery) to assess how they, and their fistula, are getting on. _x000D_ _x000D_ Recent research has shown that patients consider fistula function rather than simply bloodflow is most important when determining the success of a procedure. Therefore we will judge success if a fistula can deliver dialysis without the need for any additional procedures or surgery. This will be easy to assess in patients receiving dialysis. However, we anticipate that about half of study participants will not have started dialysis yet. In these patients the fistula will be assessed by ultrasound (jelly scan) instead. We will compare the number of patients with a successful fistula at 12 months in each group to determine which anaesthetic technique (if either) is better._x000D_ _x000D_ We will also collect information about complications (infections, blockages, needling problems), additional procedures, hospital visits or ‘lines’ (plastic tubes inserted to allow dialysis if the fistula isn’t working properly). Finally, patients will be asked to complete some short questionnaires to evaluate general wellbeing. One of the questionnaires has been recently designed by doctors specifically to look at the effect of the ‘access’ on patient lifestyle. This information will allow us to determine if the treatments are good value for money._x000D_ _x000D_ Wherever possible, patients will be followed-up in their dialysis units to avoid additional hospital visits and only hospitals that already offer both local anaesthetic and ‘block’ within their current practice will be eligible to participate. In this way we will keep down costs of running the trial and draw on existing relationships to make everything run efficiently. _x000D_ _x000D_ We anticipate that the results of this trial will be used to influence the decision-making of NHS funders and ensure that, in the future, the best treatment option is available for every patient with kidney failure in the UK.

Lay abstract: Research question: Does regional (RA) compared to local anaesthesia (LA) improve unassisted functional patency at 1-year and/or cost-effectiveness in patients undergoing primary radio- (RCF) or brachio-cephalic (BCF) fistula creation?_x000D_ Background: Arteriovenous fistulae (AVF) are the “gold standard” vascular access for haemodialysis, however universal usage is limited by a high early failure rate. Several small studies, including our own single-centre randomised controlled trial (RCT), previously demonstrated better early patency rates for AVF created under RA versus LA. The mechanistic hypothesis is that sympathetic blockade causes vasodilatation and increased blood flow through the new AVF. Despite this, considerable variation in practice exists in the UK. A high quality, adequately powered, multicentre RCT is required to definitively inform practice._x000D_ Aims and Objectives: _x000D_ • Compare functional patency for AVF created under RA vs. LA_x000D_ • Assess efficacy, safety and acceptability of RA and LA_x000D_ • Compare rates of re-intervention, complications and need for alternative accesses between RA and LA_x000D_ • Evaluate the cost-effectiveness of RA vs. LA for primary AVF creation_x000D_ Methods: We propose a multicentre, single-blinded RCT comparing RA (ultrasound-guided supraclavicular or axillary block with 1:1 mixture of 0.5% L-bupivacaine and 1% lignocaine with epinephrine) and LA (local infiltration with 0.5% L-bupivacaine and 1% lignocaine) in patients undergoing primary RCF or BCF creation. 566 patients will be recruited from up to 20 UK centres that currently offer both LA and RA within routine practice. An internal pilot with stop/go checkpoint after 4 months (95 patients) will ensure the ability to recruit._x000D_ _x000D_ The primary end point is unassisted functional patency at 1-year (defined as the ability of the access to uninterruptedly deliver the prescribed dialysis without intervention). In pre-dialysis patients, this will be defined both clinically (assessment by a blinded dialysis nurse) and ultrasonographically (4mm diameter and access flow >500ml/min). Secondary outcomes include: access-related complications e.g. infection, thrombosis; re-interventions to maintain/ re-establish patency; hospitalisation; alternative accesses; mortality; safety, efficacy and acceptability of anaesthetic technique and health-related quality of life measures (EQ-5D, KDQOL-SF and VAS-QoL (a novel vascular access specific tool). These will be assessed at 3 and 12 months. Intention-to-treat and per protocol analyses will be performed as well as health economic evaluation. A rapid feedback evaluation study will run in parallel to the main trial collecting qualitative data on recruitment and retention. Findings will be shared with the trial team on a regular basis to inform trial delivery._x000D_ _x000D_ Timeline for delivery: Recruitment will take two years. Follow-up will take one year. _x000D_ _x000D_ Anticipated impact and dissemination: Results will have direct implications for patient care across a range of medical specialties (surgery, anaesthesia, nephrology, dialysis nursing). They will be presented at international scientific conferences and published in a high impact peer-reviewed medical journal. It is anticipated that results will provide NICE level evidence to influence NHS commissioning and that recommendations be incorporated into the Renal Association’s next ‘Vascular Access for Haemodialysis’ guideline.

Research activity codes: 6.1 PHARMACEUTICALS;6.4 SURGERY
Health categories: RENAL AND UROGENITAL