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

Plain English summary of protocol

Background and study aims
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 this can be prevented 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). It is known that the ‘block’ also improves blood flow to the arm. Theoretically, this could improve the success of a fistula operation but this is not yet clear. 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’.

Who can participate?
Adult patients with either end-stage renal disease (ESRD) and receiving renal replacement therapy (RRT), or chronic kidney disease (CKD) stage IV or V and referred for arteriovenous fistula creation.

What does the study involve?
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 blood flow is most important when determining the success of a procedure. Therefore success will be judged 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, it is anticipated 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. The trial team 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.

Information will be collected 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.

What are the possible benefits and risks of participating?
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, it is hoped that the costs of running the trial will be kept down and the trial team will draw on existing relationships to make everything run efficiently.

It is anticipated 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.

Where is the study run from?
NHS Greater Glasgow and Clyde (UK)

When is the study starting and how long is it expected to run for?
From October 2020 to July 2024

Who is funding the study?
National Institute for Health Research (UK) - NIHR130567

Who is the main contact?
Dr Emma Aitken
emmaaitken@nhs.net

Contact information

Dr Emma Aitken
Scientific

Department of Renal Surgery
Queen Elizabeth University Hospital
Glasgow
G51 4TF
United Kingdom

ORCID ID	0000-0001-8939-7478
Phone	+44 (0)141 452 6209
Email	Emma.Aitken@ggc.scot.nhs.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• Northern Ireland
• Scotland
• United Kingdom

Study participating centres

Sponsor information

NHS Greater Glasgow and Clyde
Hospital/treatment centre

Grahamston Road
Paisley
PA2 7DE
Scotland
United Kingdom

Phone	+44 (0)141 314 4012
Email	Maureen.Travers@ggc.scot.nhs.uk
Website	http://www.nhsggc.org.uk/
"ROR"	https://ror.org/05kdz4d87

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

10/05/2024: The following changes were made to the study record:
1. Total final enrolment added.
2. The recruitment end date was changed from 30/04/2023 to 17/05/2024.
3. The overall study end date was changed from 31/05/2024 to 31/07/2024.
04/04/2023: The contact confirmed the record is up to date.
30/12/2021: Publication reference added.
04/06/2021: The following changes were made to the trial record:
1. The contact was updated.
2. The recruitment end date was changed from 30/05/2021 to 30/04/2023.
3. The ethics approval was added.
06/01/2021: Internal review.
16/10/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR).