The Study evaluate the non-inferiority of Test product (Chloroprocaine 2%) versus Reference product (Ropivacaine 0.75%) in terms of proportion of subjects with a successful block for distal upper limb surgeries Successful block: anaesthesia adequate for the surgery without any supplementation in the first 45 min.
This Study evaluate the non-inferiority of Test product (Chloroprocaine 2%) versus Reference product (Ropivacaine 0.75%) in terms of proportion of subjects with a successful block for distal upper limb surgeries, without any supplementation in the first 45 min (see definitions below), calculated from the time of readiness for surgery (complete sensory block). Successful block: anaesthesia adequate for the surgery (complete sensory block), without any supplementation in the first 45 min (even if surgery lasts for \> 45 min), calculated from the time of readiness for surgery (complete sensory block). Supplementation: i.v. premedication or general anaesthesia or pre- or intra-operative systemic analgesia or additional local anaesthetic infiltration
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
211
Single Administration (20mL) by Axillary Nerve Route
Single Administration (20mL) by Axillary Nerve Route
Claudio Camponovo
Gravesano, Lugano, Switzerland
Percentage of Participants With Successful Block for Distal Upper Limb Surgeries
Percentage of patients with a successful block for distal upper limb surgeries, without any supplementation in the first 45 min, calculated from the time of readiness for surgery (complete sensory block).
Time frame: 45 min from the time of readiness of surgery
Time to Onset of Sensory Block (Corresponding to Readiness for Surgery)
Time period from completion of the final perineural injection (time 0 h) to achievement of sensory block in the 4 nerve territories
Time frame: Up to 1 h after last perineural injection
Time to Onset of Motor Block
Time period from completion of the final perineural injection (time 0 h) to achievement of motor block
Time frame: Up to 1 h after last perineural injection
Time to Regression of Sensory Block
Will be deemed to have occurred when cold sensation and sensitive perception have returned (if assessable) in any nerve territory
Time frame: Up to 12 hrs after surgery
Time to Regression of Motor Block
Will be deemed to have occurred when motor score is ≥ 3 (Modified Bromage scale) in any nerve territory (Modified Bromage scale: 0-No movement in relevant muscle group,1-Flicker of movement in relevant muscle group,2-Ability to move relevant muscle group against gravity but inability to move against resistance,3-Reduced power but ability to move muscle group against resistance,4-Full power in relevant muscle group)
Time frame: Up to 12 hrs after surgery
Partecipants Received Rescue Anaesthesia or Rescue Analgesia
partecipants received rescue anaesthesia or rescue analgesia from completion of the final perineural injection (time 0 hour) to administration of first rescue anaesthesia or analgesia (supplementation)
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Time frame: 45 min from the time of readiness of surgery
Number of Subjects Who Received Post-operative Analgesia
Number of subjects who received the first post-operative analgesia
Time frame: From surgery day to 24 hrs post surgery
Time to Eligibility for Home Discharge
Time from completion of the final perineural injection (time 0 h) to the time when the criteria for discharge are met, even if, according to the hospital procedures, the patient is discharged from the hospital at a later time
Time frame: from surgery day to 24h post surgery
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Number of Participants with Treatment-emergent Adverse Events (TEAEs) occurring or worsening after the first dose of IMP
Time frame: from surgery day to day 6 +/- 1 after surgery
Neurological Symptoms
Number of patients with Neurological Symptoms (e.g. paraesthesia, motor function problems and pain at the injection site)
Time frame: from surgery day to day 6 +/- 1 after surgery
Heart Rate
The following normal ranges Heart Rate parameters will be used: 50-90 beats/min
Time frame: from surgery day to 24 hrs post surgery
Blood Pressure
The following normal ranges Systolic and Diastolic Blood Pressure parameters will be used: Systolic Blood Pressure: 100-139 mmHg Diastolic Blood Pressure: 50-89 mmHg
Time frame: from surgery day to 24 hrs post surgery
SpO2
The following normal ranges SpO2 parameters will be used: Peripheral Oxygen Saturation: ≥ 95%
Time frame: from surgery day to 24 hrs post surgery
Number of Participants With Normal Electrocardiogram (ECG) Parameters
Number of Participants with Normal Electrocardiogram (ECG) Parameters. The following normal ranges ECG parameters will be used: Heart Rate: 50-90 beats/min PR Interval: 100-220 msec QRS Duration: ≤ 120 msec QT Interval: ≤ 500 msec
Time frame: from surgery day to 24 hrs post surgery