Dataset Information

Long-Term Functional Patency and Cost-Effectiveness of Arteriovenous Fistula Creation under Regional Anesthesia: a Randomized Controlled Trial.

ABSTRACT:

Background

Regional anesthesia improves short-term blood flow through arteriovenous fistulas (AVFs). We previously demonstrated that, compared with local anesthesia, regional anesthesia improves primary AVF patency at 3 months.

Methods

To study the effects of regional versus local anesthesia on longer-term AVF patency, we performed an observer-blinded randomized controlled trial at three university hospitals in Glasgow, United Kingdom. We randomly assigned 126 patients undergoing primary radiocephalic or brachiocephalic AVF creation to receive regional anesthesia (brachial plexus block; 0.5% L-bupivacaine and 1.5% lidocaine with epinephrine) or local anesthesia (0.5% L-bupivacaine and 1% lidocaine). This report includes findings on primary, functional, and secondary patency at 12 months; reinterventions; and additional access procedures (primary outcome measures were previously reported). We analyzed data by intention to treat, and also performed cost-effectiveness analyses.

Results

At 12 months, we found higher primary patency among patients receiving regional versus local anesthesia (50 of 63 [79%] versus 37 of 63 [59%] patients; odds ratio [OR], 2.7; 95% confidence interval [95% CI], 1.6 to 3.8; P=0.02) as well as higher functional patency (43 of 63 [68%] versus 31 of 63 [49%] patients; OR, 2.1; 95% CI, 1.5 to 2.7; P=0.008). In 12 months, 21 revisional procedures, 53 new AVFs, and 50 temporary dialysis catheters were required. Regional anesthesia resulted in net savings of £195.10 (US$237.36) per patient at 1 year, and an incremental cost-effectiveness ratio of approximately £12,900 (US$15,694.20) per quality-adjusted life years over a 5-year time horizon. Results were robust after extensive sensitivity and scenario analyses.

Conclusions

Compared with local anesthesia, regional anesthesia significantly improved both primary and functional AVF patency at 1 year and is cost-effective.

Clinical trial registry name and registration number

Local Anaesthesia versus Regional Block for Arteriovenous Fistulae, NCT01706354.

SUBMITTER: Aitken E

PROVIDER: S-EPMC7460891 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:An arteriovenous fistula is the optimal form of vascular access in patients with end-stage renal failure requiring haemodialysis. Unfortunately, approximately one-third of fistulae fail at an early stage. Different anaesthetic techniques can influence factors associated with fistula success, such as intraoperative blood flow and venous diameter. A regional anaesthetic brachial plexus block results in vasodilatation and improved short- and long-term fistula flow compared to the infiltration of local anaesthetic alone. This, however, has not yet been shown in a large trial to influence long-term fistula patency, the ultimate clinical measure of success.The aim of this study is to compare whether a regional anaesthetic block, compared to local anaesthetic infiltration, can improve long-term fistula patency. METHODS:This study is an observer-blinded, randomised controlled trial. Patients scheduled to undergo creation of either brachial or radial arteriovenous fistulae will receive a study information sheet, and consent will be obtained in keeping with the Declaration of Helsinki. Patients will be randomised to receive either: (i) an ultrasound guided brachial plexus block using lignocaine with adrenaline and levobupivicaine, or (ii) local anaesthetic infiltration with lignocaine and levobupivicaine.A total of 126 patients will be recruited. The primary outcome is fistula primary patency at three months. Secondary outcomes include primary patency at 1 and 12 months, secondary patency and fistula flow at 1, 3 and 12 months, flow on first haemodialysis, procedural pain, patient satisfaction, change in cephalic vein diameter pre- and post-anaesthetic, change in radial or brachial artery flow pre- and post-anaesthetic, alteration of the surgical plan after anaesthesia as guided by vascular mapping with ultrasound, and fistula infection requiring antibiotics. CONCLUSIONS:No large randomised controlled trial has examined the influence of brachial plexus block compared with local anaesthetic infiltration on the long-term patency of arteriovenous fistulae. If the performance of brachial plexus block increases fistulae patency, this will have significant clinical and financial benefits as the number of patients able to commence haemodialysis when planned should increase, and the number of "redo" or revision procedures should be reduced. TRIAL REGISTRATION:This study has been approved by the West of Scotland Research Ethics Committee 5 (reference no. 12/WS/0199) and is registered with the ClinicalTrials.gov database (reference no. NCT01706354).

Project description:BackgroundArticaine has emerged as a local anesthetic (LA) that produces sensory and motor blockade shorter than bupivacaine and lower in neurotoxicity than lidocaine. Studies have shown that adding dexmedetomidine to LA produces prolongation of sensory and motor bock duration. Early regain of motor power with adequate analgesia is needed in hemodialysis fistula creation surgery, for early start of physiotherapy. We designed this study to test efficacy of adding dexmedetomidine to articaine on the duration of sensory and motor block.MethodsAfter university review board approval, written informed consent to participate in the study was obtained. Patients with chronic renal failure undergoing radiocephalic hemodialysis fistula creation were eligible for enrollment in this double-blind, randomized trial. Patients receive either 40 ml of 2% articaine hydrochloride or 40 ml of articaine 2% mixed with dexmedetomidine (1 μg.kg - 1). Sensory block duration in minutes is assessed by pinprick test and motor block duration in minutes is tested by Bromage scale; both are recorded as a primary outcome. Secondary outcomes, including onset of sensory and motor block, time for rescue analgesia, hemodynamic changes, oversedation, and possible side effect, were recorded.ResultsFifty patients were enrolled in the study (25 in the articaine Group A and 25 in the articaine and dexmedetomidine group [AD]). Longer sensory block duration was in Group AD (230-260 min) than in Group A (172-185 min) with P < 0.001. In addition, motor block duration was significantly longer in Group AD than in Group A, (220 ± 110 min), (165 ± 45 min), respectively. The duration of effective analgesia was significantly longer in Group AD (363 ± 134 min) versus in Group A (244 ± 84 min). The onset of block was short and similar between groups.ConclusionAddition of dexmedetomidine to articaine during arteriovenous fistula creation provide prolongation of sensory and motor block duration and augment analgesia.Trial registrationThis trial was registered at Clinical trial.gov https://clinicaltrials.gov/ct2/show/NCT04171349 with the identification number NCT04171349.

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