Safety and performance of a novel device for the administration of regional anaesthesia

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)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN20659914

Enrollment

Registered

2022-01-27

Start date

2021-11-22

Completion date

Unknown

Last updated

2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 syst

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 comple

ii) Routine clinical data (or clinical data potentially available for collection without impacting on patient care) in patients u

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: 1. PNB procedures involving patients aged < 18 years 2. PNB procedures involving (pre-scheduled) continuous PNB

Design outcomes

Primary

Measure	Time frame
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. 2. Composite measure of block success at 'Day 0'. This will be defined as adequate block (sufficient blocking of the transmission of nerve impulses as assessed by routine institutional sensory and/or motor testing protocol to allow surgery to proceed) AND no block conversion (avoidance of rescue block) NB: both composite and separate measures of block success will be reported. 3. Safety at ‘Day 0’ measured using a composite measure of evidence of potential acute nerve injury. This will be defined as any patient-reported severe and painful symptoms such as tingling, prickling, burning, uncomfortable pins and needles or any type of electric shock sensation during the PNB procedure AND suspected or confirmed needle-nerve contact, intraneural needle penetration or intrafascicular needle penetration as reported by the anaesthetist NB: both composite and separate measures of potential nerve injury will be reported. 4. Safety at ‘Day 30’ measured using evidence of persistent nerve injury. This will be defined as any documented evidence in the patient medical records of sensory and/or motor deficit including: i) patient-reported chronic, severe and painful symptoms such as tingling, prickling, burning, uncomfortable pins and needles or any type of electric shock sensation; ii) patient-reported limb or muscle weakness or iii) clinician-observed sensory and/or motor deficit lasting longer than 48 hours after surgery. Sensory and/or motor deficit in a different regional area to that of the PNB will be recorded but will be considered separately to sensory and/or motor deficit in the regional area of the PNB.	—

Measure

Time frame

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. 2. Composite measure of block success at 'Day 0'. This will be defined as adequate block (sufficient blocking of the transmission of nerve impulses as assessed by routine institutional sensory and/or motor testing protocol to allow surgery to proceed) AND no block conversion (avoidance of rescue block) NB: both composite and separate measures of block success will be reported. 3. Safety at ‘Day 0’ measured using a composite measure of evidence of potential acute nerve injury. This will be defined as any patient-reported severe and painful symptoms such as tingling, prickling, burning, uncomfortable pins and needles or any type of electric shock sensation during the PNB procedure AND suspected or confirmed needle-nerve contact, intraneural needle penetration or intrafascicular needle penetration as reported by the anaesthetist NB: both composite and separate measures of potential nerve injury will be reported. 4. Safety at ‘Day 30’ measured using evidence of persistent nerve injury. This will be defined as any documented evidence in the patient medical records of sensory and/or motor deficit including: i) patient-reported chronic, severe and painful symptoms such as tingling, prickling, burning, uncomfortable pins and needles or any type of electric shock sensation; ii) patient-reported limb or muscle weakness or iii) clinician-observed sensory and/or motor deficit lasting longer than 48 hours after surgery. Sensory and/or motor deficit in a different regional area to that of the PNB will be recorded but will be considered separately to sensory and/or motor deficit in the regional area of the PNB.

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Secondary

Measure	Time frame
Measured at 'Day 0' using patient records and questionnaire completed by anaesthetists: 1. Number of needle punctures (any new needle insertion through skin) 2. Number of needle redirects (any needle insertion-withdrawal-insertion of =10mm) 3. Block onset time (interval between completion of LA injection and adequate sensory block to permit surgery in distribution of blocked nerve) 4. Event-free SAFIRA assembly/deployment (any suspected or reported issue in any of the steps of the SAFIRA Instruction for Use) 5. SAFIRA malfunction/failure (any event requiring conversion to manual injection) 6. Major complications (cardiac arrest, pneumothorax, death, other (specify)) 7. Minor complications (vascular puncture, haematoma, local anaesthetic toxicity, cardiac arrhythmia, systemic hypotension, other (specify)) 8. LA volume required 9. Anaesthetists appraisal of the SAFIRA system after completing all each PNB procedure 10. Injection Pressure (How important is limiting LA opening/injection pressure in your own clinical practice: Not at all important/Quite unimportant/Neither unimportant or important/Quite important/Very important) 11. Ease of Use (Compared to usual practice SAFIRA is easy to use: Strongly disagree/Disagree/Neither disagree or agree/Agree/Strongly agree) 12. Effectiveness (Compared to usual practice SAFIRA is effective: Strongly disagree/Disagree/Neither disagree or agree/Agree/Strongly agree) 13. Drawbacks (Compared to usual practice SAFIRA has few drawbacks: Strongly disagree/Disagree/Neither disagree or agree/Agree/Strongly agree) 14. Workload (Compared to usual practice SAFIRA increases workload: Strongly disagree/Disagree/Neither disagree or agree/Agree/Strongly agree) 15. Preference (Compared to usual practice I pref	—

Measure

Time frame

Measured at 'Day 0' using patient records and questionnaire completed by anaesthetists: 1. Number of needle punctures (any new needle insertion through skin) 2. Number of needle redirects (any needle insertion-withdrawal-insertion of =10mm) 3. Block onset time (interval between completion of LA injection and adequate sensory block to permit surgery in distribution of blocked nerve) 4. Event-free SAFIRA assembly/deployment (any suspected or reported issue in any of the steps of the SAFIRA Instruction for Use) 5. SAFIRA malfunction/failure (any event requiring conversion to manual injection) 6. Major complications (cardiac arrest, pneumothorax, death, other (specify)) 7. Minor complications (vascular puncture, haematoma, local anaesthetic toxicity, cardiac arrhythmia, systemic hypotension, other (specify)) 8. LA volume required 9. Anaesthetists appraisal of the SAFIRA system after completing all each PNB procedure 10. Injection Pressure (How important is limiting LA opening/injection pressure in your own clinical practice: Not at all important/Quite unimportant/Neither unimportant or important/Quite important/Very important) 11. Ease of Use (Compared to usual practice SAFIRA is easy to use: Strongly disagree/Disagree/Neither disagree or agree/Agree/Strongly agree) 12. Effectiveness (Compared to usual practice SAFIRA is effective: Strongly disagree/Disagree/Neither disagree or agree/Agree/Strongly agree) 13. Drawbacks (Compared to usual practice SAFIRA has few drawbacks: Strongly disagree/Disagree/Neither disagree or agree/Agree/Strongly agree) 14. Workload (Compared to usual practice SAFIRA increases workload: Strongly disagree/Disagree/Neither disagree or agree/Agree/Strongly agree) 15. Preference (Compared to usual practice I pref

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026