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  • #35899 Post-market clinical investigation of safety, performance and anaesthetist satisfaction of the ‘Safe injection for regional anaesthesia’ (safira) device in ultrasound guided peripheral nerve blockade

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Peripheral nerve blocks
#35899 Post-market clinical investigation of safety, performance and anaesthetist satisfaction of the ‘Safe injection for regional anaesthesia’ (safira) device in ultrasound guided peripheral nerve blockade
  1. Theresa Murray1,
  2. Ben Fox2,
  3. Alwin Chuan3,
  4. Lee Smith4,
  5. Ben Cracknell5,
  6. Minh Tran6 and
  7. Ryan Ting7
  1. 1Specialty Registrar Anaesthesia ST7, Addenbrookes, Cambridge University Hospital, Cambridge, UK
  2. 2Consultant Anaesthetist, QEHKL, hospitality and honorarium Medovate and Sintetica, Kings Lynn, UK
  3. 3Associate Professor, South West Sydney Clinical School, UNSW Australia, Sydney, Australia
  4. 4Professor Public Health , Centre for Health and Well Being, Anglia Ruskin University, Cambridge, UK
  5. 5Specialty Registrar Anaesthesia, Norfolk and Norwich Hospital, Norwich, UK
  6. 6Doctor, South West Sydney Clinical School, UNSW Australia, Sydney, Australia
  7. 7Student, South West Sydney Clinical School, UNSW Australia, Sydney, Australia

Abstract

Please confirm that an ethics committee approval has been applied for or granted: Yes: I’m uploading the Ethics Committee Approval as a PDF file with this abstract submission

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.

Abstract #35899 Figure 1
Abstract #35899 Figure 1

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.

Attachment 293036_Letter_of_HRA_Approval_22032021.pdf

  • innovation
  • safety
  • nerve injury
  • safira
  • regional anaesthesia

https://doi.org/10.1136/rapm-2023-ESRA.521

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