The SAFIRA PMCF Study
Research type
Research Study
Full title
Prospective, open, non-controlled, single-arm post-market clinical follow-up investigation to confirm the safety and performance of the SAFIRA system in ultrasound guidance and/or nerve stimulation peripheral nerve block.
IRAS ID
293036
Contact name
Benjamin Fox
Contact email
Sponsor organisation
Queen Elizabeth Hospital King's Lynn Foundation Trust
Duration of Study in the UK
0 years, 3 months, 1 days
Research summary
Unintentional needle-to-nerve contact, intraneural penetration or intrafascicular penetration during peripheral nerve block (PNB) may cause nerve injury which, even if minor and transient, presents a sizeable problem when the number of PNB procedures are scaled-up to a healthcare system or population level. Patients experiencing more severe and/or persistent nerve injury may experience significant negative consequences in terms of decreased health status, physical function, ability to work and quality of life. Meta-analyses have identified that Anaesthetists cannot rely on nerve stimulation (NS) and ultrasound guidance (UG), ‘syringe-feel’ or injection pressure monitoring as indicators of unintentional needle-to-nerve contact, intraneural penetration or intrafascicular penetration. It is possible that the safest way of preventing nerve damage might be to automatically limit local anesthetic (LA) opening and injection pressure to levels that are not associated with nerve damage. The SAFIRA system is a medical device that limits LA opening and injection pressures to a level of >20psi. This study will assess the safety and performance of SAFIRA (SAFe Injection for Regional Anaesthesia) in a ‘real-world’ clinical setting.
SAFIRA is a novel single-operator medical device that has European regulatory approval (CE mark) and Section 510(k) FDA approval. The SAFIRA system monitors and gives accurate and objective real-time feedback on PNB opening pressure and injection pressure which alerts the anaesthetist to high pressures and provides a stimulus to modify technique to prevent potential nerve injury. Furthermore, unlike passive pressure monitoring systems SAFIRA has a pre-set pressure threshold which activates if opening or injection pressures reach a level of >20psi. Although SAFIRA has been comprehensively examined through the process of Clinical Evaluation, safety and performance have not yet been established in a clinical setting.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
21/ES/0029
Date of REC Opinion
22 Mar 2021
REC opinion
Further Information Favourable Opinion