CompletedNot ApplicableInterventional

Investigating local or regional anaesthesia during surgery to create a connection between an artery and a vein

People with advanced kidney disease often need dialysis to clean their blood. The best way to connect to a dialysis machine is through an arteriovenous fistula, which is a small surgical connection made between an artery and a vein in the arm. Sadly, up to half of all fistulas stop working within their first year. Surgeons can numb the arm for this operation in two ways: a local anaesthetic injection directly around the cut, or a nerve block that numbs the entire arm from the neck or armpit. Nerve blocks temporarily boost blood flow, which might help the fistula heal and work better. This study compares both numbing methods to find out which one gives patients the best long-term results. Participants are randomly placed into one of the two groups and followed up for 12 months.

At a glance

Status

Completed

Phase

Not Applicable

Sponsor

NHS Greater Glasgow and Clyde

Enrolment target

566

Start

01 May 2021

Estimated completion

17 May 2024

Patients undergoing primary (Radiocephalic fistula) RCF or (Brachiocephalic fistula) creation

What is this study about?

For people living with severe kidney disease, dialysis is often a vital, life-saving treatment. Dialysis acts as an artificial kidney, taking blood out of the body, filtering away waste products and extra fluid, and returning the clean blood back into the bloodstream. To do this easily and safely, surgeons create a 'fistula' by joining an artery to a vein, usually in the wrist or elbow. This makes the vein wider and stronger so it can handle regular dialysis needles. However, creating a successful fistula can be challenging, and around half of them stop working within the first year.

When you have fistula surgery, the medical team needs to numb your arm so you do not feel pain. Currently, NHS hospitals use two main approaches. One is a standard local anaesthetic, where medicine is injected right around the area of the cut. The other is a regional nerve block, where anaesthetic is injected near the nerves in your neck or armpit to numb the whole arm for several hours. A regional block also relaxes the blood vessels and increases blood flow to the arm, which experts think might help the fistula form better and stay open longer.

At the moment, there is no national agreement in the UK on which numbing method is best, so hospitals simply use whichever one they prefer. The ACCess trial aims to settle this question by comparing both techniques directly. By tracking how well fistulas work over a 12-month period, this study hopes to help NHS doctors choose the most effective approach, improving long-term care for kidney patients across the country.

Key takeaways

The ACCess study compares two standard ways to numb the arm during fistula surgery.
A computer randomly assigns you to either a local numbing injection or a regional nerve block.
The main goal is to find out which method keeps fistulas working better after 12 months.
Follow-up checks happen at 3 and 12 months, usually alongside your normal clinic visits.
Joining the study is completely voluntary, and you can withdraw at any time.

Who may be eligible?

You may be able to join this study if you are 18 or older and have advanced kidney disease (stage 4 or 5) or kidney failure, and your care team has referred you for your first fistula operation in your wrist or elbow. Both men and women can take part.

You cannot join if you prefer to have a general anaesthetic (being put to sleep) for your surgery, or if you have had a working fistula in the same arm before. You also will not be able to participate if you have an active skin infection near the surgery site, a known allergy to numbing medicines, or serious nerve problems in that arm.

In addition, people with certain bleeding conditions, those taking blood-thinning medicines that cannot be safely paused, or individuals who weigh under 45 kg (about 7 stone) cannot take part. Before surgery, the team will perform a quick ultrasound scan to check that the blood vessels in your arm are wide enough for the procedure.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or over.
I have stage 4 or 5 chronic kidney disease or kidney failure.
I am scheduled to have a new fistula created in my wrist or elbow.
I have not had a working fistula in that same arm before.
I am happy to have my operation while awake using local or regional numbing.
I weigh at least 45 kg (around 7 stone).

Answer every question to see your result.

What does participation involve?

If you decide to take part, a computer will randomly choose which numbing method you receive on the day of your surgery. You will have an equal chance of receiving either the standard local numbing injection around the cut or the regional nerve block that numbs your entire arm. Both are routine NHS procedures. Most people have their surgery as a day case and go home the same day.

Your total time in the study will be about 12 months. You will have two planned check-ups: one at 3 months and another at 12 months after your operation. Wherever possible, these reviews will take place during your normal dialysis visits to save you making extra trips to hospital. If you have not yet started dialysis, the team will check your fistula using a painless ultrasound jelly scan. You will also be asked to fill in a few short questionnaires about your health, daily wellbeing, and how the fistula affects your life.

Potential risks and benefits

Taking part may not benefit you directly, as both numbing techniques are already standard NHS options. However, your involvement could help doctors understand which method helps fistulas last longer, improving care for future kidney patients. The risks are the same as having routine fistula surgery and anaesthesia, such as mild bruising, temporary nerve tingling, or a small chance of infection. You are completely free to leave the study at any point without giving a reason, and your regular NHS medical care will not be affected in any way.

Locations (16)

Queen Elizabeth University Hospital
Approximate
Glasgow, Scotland
Stobhill Ambulatory Care Hospital
City only
Glasgow, Scotland
Addenbrookes Hospital
City only
Cambridge, England
Belfast City Hospital
Approximate
Belfast, Northern Ireland
Bradford Royal Infirmary
Approximate
Bradford, England
Dumfries and Galloway Royal Infirmary
Unverified
Dumfires, Scotland
The Freeman Hospital
Unverified
Newcastle upon Tyne, England
Guy's and St Thomas' NHS Foundation Trust
Unverified
London, England
The James Cook University Hospital
Unverified
Middlesbrough, England
University Hospital Monklands
Unverified
Airdrie, Scotland
University Hospital Hairmyres
Unverified
Glasgow, Scotland
Leeds General Infirmary
Unverified
Leeds, England

Common questions

Will I be awake during the operation?

Yes. Both local anaesthesia and nerve blocks keep you awake, but your arm will be completely numb so that you feel no pain during the surgery.

Can I choose which numbing method I get?

No. A computer randomly decides which method you receive, like tossing a coin. This ensures the study gives fair, unbiased results.

What happens if my fistula stops working during the study?

Your kidney team will care for you exactly as they normally would, offering any tests, repairs, or alternative dialysis access you might need.

Will I need to make extra visits to the hospital?

The researchers aim to do study checks during your routine dialysis sessions or regular clinic appointments, keeping extra travel to a minimum.

Do I have to pay anything or will I be paid?

No, taking part is free through the NHS, and you will not receive payment for participating in this study.

How to find out more

Emma Aitken

Emma.Aitken@ggc.scot.nhs.uk +44 (0)141 452 6209 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.