A RCT trial in hemodialysis patients: fistula
Lancet. 2016 Sep 10;388(10049):1067-74. doi: 10.1016/S0140-6736(16)30948-5. Epub 2016 Aug 1.
Effect of regional versus local anaesthesia on outcome after arteriovenous fistula creation: a randomised controlled trial.
Arteriovenous fistulae are the optimum form of vascular access in end-stage renal failure. However, they have a high early failure rate. Regional compared with local anaesthesia results in greater vasodilatation and increases short-term blood flow. This study investigated whether regional compared with local anaesthesia improved medium-term arteriovenous fistula patency.
This observer-blinded, randomised controlled trial was done at three university hospitals in Glasgow, UK. Adults undergoing primary radiocephalic or brachiocephalic arteriovenous fistula creation were randomly assigned (1:1; in blocks of eight) using a computer-generated allocation system to receive either local anaesthesia (0·5% L-bupivacaine and 1% lidocaine injected subcutaneously) or regional (brachial plexus block [BPB]) anaesthesia (0·5% L-bupivacaine and 1·5% lidocaine with epinephrine). Patients were excluded if they were coagulopathic, had no suitable vessels, or had a previous failed ipsilateral fistula. The primary endpoint was arteriovenous fistula patency at 3 months. We analysed the data on an intention-to-treat basis. This study was registered with ClinicalTrials.gov (NCT01706354) and is complete.
Between Feb 6, 2013, and Dec 4, 2015, 163 patients were assessed for eligibility and 126 patients were randomly assigned to local anaesthesia (n=63) or BPB (n=63). All patients completed follow-up on an intention-to-treat basis. Primary patency at 3 months was higher in the BPB group than the local anaesthesia group (53 [84%] of 63 patients vs 39 [62%] of 63; odds ratio [OR] 3·3 [95% CI 1·4-7·6], p=0·005) and was greater in radiocephalic fistulae (20 [77%] of 26 patients vs 12 [48%] of 25; OR 3·6 [1·4-3·6], p=0·03). There were no significant adverse events related to the procedure.
Compared with local anaesthesia, BPB significantly improved 3 month primary patency rates for arteriovenous fistulae.
Not so frequent to have a RCT on Fistula patency. Basically, the study design is simple. The rationale is also simple and makes sense. Eventually, the results are clear…and positive: regional aneasthesia (Brachial Plexus Block) does improve FAV maturation and patency after 3 months. The procedure is relatively easy but requires some expertise, formation and materials (echography). Moreover, one important point must be underlined: a good patency is also dependent of a good surgeon! Regional aneasthesia implies that surgeon did the fistula within one hour…