Patients undergoing primary (Radiocephalic fistula) RCF or (Brachiocephalic fistula) creation Surgery Surgically created arteriovenous fistula
Conditions
Interventions
Each participant will be randomised, at a ratio of 1:1, to either receive Regional Anaesthesia (RA) or Local Anaesthesia (LA) during their planned surgery to create a connection between an artery and
Sponsors
NHS Greater Glasgow and Clyde
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Aged >18 years 2. End-stage renal disease (ESRD) and receiving renal replacement therapy (RRT), or chronic kidney disease (CKD) stage IV or V and referred for primary radiocephalic (RCF) or brachiocephalic (BCF) fistula creation
Exclusion criteria
Exclusion criteria: 1. Unable or unwilling to provide informed consent 2. Preference for general or alternative anaesthesia 3. Active infection at surgical or anaesthetic site 4. Previous ipsilateral arteriovenous fistula (AVF) creation (a previous attempt at distal AVF creation which fails immediately is not considered a contraindication, however any distal access which has previously run sufficiently to mature the outflow vein or proximal revision of an existing AVF is considered a contraindication) 5. Known ipsilateral cephalic arch or central venous stenosis (even if previously treated) 6. USS evidence of stenosis in inflow artery 7. Radial or brachial artery 1.4 10. Significant pre-existing neurological disorder affecting the upper limb 11. Weight <45 kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Unassisted functional arteriovenous fistula (AVF) patency at 1 year measured as the ability of access to uninterruptedly deliver the prescribed dialysis without intervention at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Vascular access complications (e.g. infection, stenosis, steal, thrombosis, bleeding) measured at 3 and 12 months 2. Re-operation/re-intervention measured using the number of re-operations/re-interventions at 3 and 12 months 3. Alternative accesses measured using alternative access requirements at 3 and 12 months 4. Cannulation difficulties measured using access complications (inc infection, stenosis, thrombosis, steal, bleeding) at 3 and 12 months 5. Mortality measured using the number of deaths at 3 and 12 months 6. Dialysis and access modality measured using change of renal replacement therapy at 3 and 12 months 7. Access-related hospitalisation measured using a number of re-operation/re-intervention required to maintain or re-establish patency (revisional surgery, angioplasty, stenting or thrombectomy) at 3 and 12 months 8. Health-related quality of life (HR-QoL) measured using patient-reported questionnaires at 3 and 12 months 9. Cost-effectiveness measured at 3 and 12 months 10. Efficacy and safety of anaesthesia measured using perioperative pain score on a numeric rating scale (NRS 0-10) and collection of relevant adverse events at 3 and 12 months | — |
Countries
England, Northern Ireland, Scotland, United Kingdom
Outcome results
None listed