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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Benjamin Fox
+44 1553613583
benjamin.fox@qehkl.nhs.uk


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Be Part of Research - Trial Details - Safety and performance of a novel device for the administration of regional anaesthesia
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Safety and performance of a novel device for the administration of regional anaesthesia

Not Recruiting

Open to: All Genders

Age: Adult

King's Lynn

Medical Conditions

Safety and performance of the SAFIRA system in ultrasound guidance and/or nerve stimulation peripheral nerve block

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Regional anaesthesia procedures require two operators - an anaesthetist who holds an ultrasound scanner and uses this to guide the needle tip placement and a second operator to inject the anaesthetic solution at a required pressure.
It has been reported that anaesthetic solutions are often injected at high pressure.
High pressure can cause damage to nerve fascicles, with serious nerve damage occurring in up to 1% of procedures and transient nerve damage in up to 8% of cases.
SAFIRA® - SAFer Injection for Regional Anaesthesia - allows a single operator, an anaesthetist or anesthesiologist, to conduct the whole regional block at safer pressures.

The study will examine the following questions:
• Does the SAFIRA device perform as intended in routine clinical practice?
• Is the SAFIRA device safe to use as per intended use?
• What is the user feedback regarding acceptability of and confidence in SAFIRA?

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

22 Nov 2021 01 Mar 2022

This study will involve 43 regional anaesthesia procedures undertaken by six anaesthetists already trained in the use of the SAFIRA system in one UK hospital site, in order to ascertain the safety and performance of SAFIRA in a ‘real-world’ clinical setting. The study will be entirely observational. The investigation will not involve any clinical investigation or treatment additional to standard care and will not include any patient-orientated research instruments. All patients will undergo treatment according to normal clinical practice.


Peripheral nerve block (PNB) procedures involving patients aged > 18 years referred for any type of elective surgery suitable for PNB and who are offered and agree to surgery that will be performed via any ultrasound guidance and/ or nerve stimulation single-injection PNB regional anaesthesia. Any type of PNB will be included in the study.

You can take part if:



You may not be able to take part if:


1. PNB procedures involving patients aged < 18 years2. PNB procedures involving (pre-scheduled) continuous PNB


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Queen Elizabeth Hospital King's Lynn Foundation Trust
    Gayton Road
    King's Lynn
    PE30 4ET

Unintentional needle-to-nerve contact, intraneural penetration or intrafascicular penetration during 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 ultra sound guidance, nerve stimulation, ‘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 anaesthetic (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 in a ‘real-world’ clinical setting. It is important to note that the SAFIRA system has all necessary approvals and is currently in use within the NHS.

Dr Benjamin Fox
+44 1553613583
benjamin.fox@qehkl.nhs.uk



The study is sponsored by Queen Elizabeth Hospital King's Lynn NHS Foundation Trust and funded by Medovate Ltd..



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Read full details for Trial ID: ISRCTN20659914
Last updated 27 January 2022

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