ACCess study
Research type
Research Study
Full title
Anaesethesia Choice for Creation of artEriovenouS fiStulae
IRAS ID
290482
Contact name
Emma Aitken
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
ISRCTN Number
ISRCTN14153938
Duration of Study in the UK
3 years, 1 months, 1 days
Research summary
Many patients with kidney failure need 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).
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.
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 or armpit to numb the entire arm for many hours). We know 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.
This study aims to compare the success of fistulas created under local anaesthetic versus an anaesthetic ‘block’.
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.
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.
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.
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.
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.REC name
West of Scotland REC 3
REC reference
20/WS/0178
Date of REC Opinion
15 Dec 2020
REC opinion
Favourable Opinion