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Background and Aims Mechanisms of nerve injury related to a peripheral nerve block (PNB) include mechanical trauma, ischaemia and local anaesthetic toxicity. The SAFIRA device aims to reduce risk of mechanical nerve injury. It comprises a motor unit allowing user to aspirate and inject local anaesthetic (LA) on demand preventing LA infiltration pressure over 20 PSI. This study is an international, multicentre, observational, prospective, non- controlled post- market clinical follow up investigation.
Methods Peripheral nerve blocks by anaesthetists trained on SAFIRA were recruited across two sites. Inclusion criteria included patients 18 plus years undergoing elective orthopaedic surgery suitable for PNB. Data yielded included demographic data, PNB type and time to perform & assessment of safety and usefulness of the device and 30 day post PNB follow up. Ethics approval was granted from HRA & HCRW.
Results 128 PNB were conducted with the SAFIRA device (64 from each site). All blocks were successful with no permanent complications reported. 9 patients experienced transient symptoms on initial injection. 3 device malfunctions were reported and due to user error. 82% of the anaesthetists expressed preference for using SAFIRA device.
Conclusions This study indicates SAFIRA device is safe & effective. We recommend local standard operating procedures are developed to minimise human error. Anecdotally some of the anaesthetists in the study reported using less volume of local anaesthetic compared to their usual practice. This could represent an unintended, but very useful, benefit of the device and warrants further study.
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