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Pilot and feasibility study investigating the effects of general anaesthesia vs. regional anaesthesia on arteriovenous fistula patency.

General vs. Regional Anaesthesia on arteriovenous Fistula patency (GiRAF): a randomised controlled pilot and feasibility trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001769178
Acronym
GiRAF
Enrollment
5
Registered
2019-12-12
Start date
2020-10-02
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients who require the creation of a new arteriovenous fistula for future haemodialysis will be recruited for this study. They will have a 50/50 chance of being assigned to receive either a brachial plexus block or a general anaesthetic technique for this operation. The main aim of this small trial is to determine if it will be feasible to perform a future larger trial comparing the effects of these two techniques on arteriovenous fistula patency. Therefore, the dual key outcomes for this trial are the proportion of eligible patients successfully recruited and the ability to complete the desired data collection for all recruited patients.

Interventions

Brachial plexus block using any established technique e.g. supraclavicular appraoch, infraclavicular approach and axillary approach using ultrasound guidance, according to anaesthetist preference. A minimum of 20 minutes after block completion is required prior to surgery, in order to assess block success. Local anaesthetic solution for the block will be 1.5% lignocaine + 1 in 200,000 adrenaline together with 1% ropivacaine mixed in a 1:1 ratio. Minimum volume of local anaesthetic will be 0.3

Brachial plexus block using any established technique e.g. supraclavicular appraoch, infraclavicular approach and axillary approach using ultrasound guidance, according to anaesthetist preference. A minimum of 20 minutes after block completion is required prior to surgery, in order to assess block success. Local anaesthetic solution for the block will be 1.5% lignocaine + 1 in 200,000 adrenaline together with 1% ropivacaine mixed in a 1:1 ratio. Minimum volume of local anaesthetic will be 0.3ml/kg if <66kg or 20ml of solution if >66kg. Maximum volume will be 0.3ml/kg if <133kg or 40 ml if >133kg. (This ensures that maximum volumes do not exceed 1.5mg/kg of ropivacaine and 3.5mg/kg of lignocaine.) Block success will be determined by a documented change in sensation or motor function in the upper limb within 20 minutes of block completion.

Sponsors

Dr Raymond Hu
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adult patients (>18 years). Stage 4 or 5 chronic kidney disease (CKD) who are undergoing or planning to undergo haemodialysis (HD) within 12 months. Planned de novo AVF surgery in an upper limb. Informed consent.

Exclusion criteria

Pregnant women Patient refusal or inability to consent. Clinician (surgeon or anaesthetist) decision not to participate (e.g. lack of experience with brachial plexus block). Contraindications to brachial plexus block (e.g. infection at site of brachial plexus block, coagulopathy, allergy to any local anaesthetic component). Use of arteriovenous graft material intended. Any prior AVF surgery on operative upper limb or revision surgery. Concurrent surgery on other parts of the body at index procedure.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026