Safety and performance of a novel device for the administration of regional anaesthesia
| ISRCTN | ISRCTN20659914 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20659914 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 293036 |
| Protocol serial number | IRAS 293036 |
| Sponsor | Queen Elizabeth Hospital King's Lynn NHS Foundation Trust |
| Funder | Medovate Ltd. |
- Submission date
- 22/12/2021
- Registration date
- 27/01/2022
- Last edited
- 27/01/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
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?
Who can participate?
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.
What does the study involve?
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.
What are the possible benefits and risks of participating?
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.
Where is the study run from?
Queen Elizabeth Hospital NHS Foundation Trust King's Lynn (UK)
When is the study starting and how long is it expected to run for?
March 2021 to March 2022
Who is funding the study?
Medovate Ltd (UK)
Who is the main contact?
Dr Benjamin Fox, benjamin.fox@qehkl.nhs.uk
Contact information
Principal investigator
Queen Elizabeth Hospital King's Lynn NHS Foundation Trust
King's Lynn
CB1 1PT
United Kingdom
| Phone | +44 1553613583 |
|---|---|
| benjamin.fox@qehkl.nhs.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective open non-controlled single-arm post-market clinical follow-up investigation |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific 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 (PNB) |
| Study objectives | The study will examine: • Does the SAFIRA device perform as intended in routine clinical practice? • Is the SAFIRA device safe to use as per intended use, are the known risks acceptable and do any new risks identified impact the benefit-risk ratio? • What, if any, is the impact on the clinical workflow of PNB procedures when using SAFIRA compared with standard practice? • What is the user feedback regarding acceptability of and confidence in SAFIRA for performing PNB procedures? |
| Ethics approval(s) | Approved 22/03/2021, HRA and Health and Care Research Wales (HCRW) (HRA, NHSBT Newcastle Blood Donor Centre, Holland Dr, Newcastle upon Tyne NE2 4NQ, UK; +44 207 972545; HCRW.approvals@wales.nhs.uk), ref: 21/ES/0029 |
| Health condition(s) or problem(s) studied | Safety and performance of the SAFIRA system in ultrasound guidance and/or nerve stimulation peripheral nerve block |
| Intervention | This prospective, open, non-controlled, single-arm post-market clinical follow-up investigation will involve 43 PNB procedures undertaken by up to 6 anaesthetists 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. For the purposes of the study any operation that requires more than one simultaneous PNB (e.g. for complex lower limb surgery) will be considered a single PNB procedure. The study will be entirely observational. The investigation will not involve allocation (or withholding) of any aspect of clinical care, will not involve any clinical investigation or treatment additional to standard care and will not include any patient-orientated research instruments (e.g. multidimensional pain questionnaires) unless routinely used at participating sites. All patients will undergo treatment according to normal clinical practice i.e. as determined by local institutional protocol and/or individual clinician discretion. The principal units of analysis will be PNB procedures undertaken with the SAFIRA system and various procedure-related, patient-related and operator-related variables will be assessed. In summary, at the participating site a study assessor (SA) - a trained member of the care team not directly involved in the care of patients within the study - will record the following data: i) Procedural data related to anaesthetists use of the SAFIRA system in patients undergoing any type of elective surgery via any type of PNB involving ultrasound guidance or nerve stimulation; ii) Routine clinical data (or clinical data potentially available for collection without impacting on patient care) in patients undergoing SAFIRA PNB procedures iii) Anaesthetists appraisal of the SAFIRA system. The study will not consider outcome measures of any of the surgeries undertaken using PNB nor will it consider the underlying effectiveness of ultrasound guidance or nerve stimulation. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | SAFIRA system |
| Primary outcome measure(s) |
1. Time to perform block at ‘Day 0’. This will be defined as time from the first application of the probe on skin for ultrasound guidance or first application of needle on the skin for nerve stimulation to final removal of the PNB local anaesthetic needle. |
| Key secondary outcome measure(s) |
Measured at 'Day 0' using patient records and questionnaire completed by anaesthetists: |
| Completion date | 22/03/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 43 |
| Key inclusion criteria | 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. |
| Key exclusion criteria | 1. PNB procedures involving patients aged < 18 years 2. PNB procedures involving (pre-scheduled) continuous PNB |
| Date of first enrolment | 22/11/2021 |
| Date of final enrolment | 01/03/2022 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
King's Lynn
PE30 4ET
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 2.0 | 04/01/2022 | No | No |
Additional files
- 40848 Protocol v2.0.pdf
- Protocol file
Editorial Notes
04/01/2022: Trial's existence confirmed by NHS HRA
