Local anaesthesia by axillary nerve block MedDRA version: 19.1 Level: PT Classification code 10024758 Term: Local anaesthesia System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Ampres 20mg/ml solution injectable
Product Name: Chloroprocaine HCl 2% (20 mg/mL)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CHLOROPROCAINE HYDROCHLORIDE
CAS Number:
Sponsors
Sintetica S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sex and surgery: male and female patients scheduled for short duration (=65 years) yes F.1.3.1 Number of subjects for this age range 61
Exclusion criteria
Exclusion criteria: 1. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study. Contraindications to peripheral nerve block anaesthesia. History of neuromuscular diseases to the upper extremities 2. Axillary status: Axillary local infections, surgical scarring and pathological lymph node enlargement 3. ASA physical status: IV-V 4. Further anaesthesia: Patients anticipated to be requiring further anaesthesia (general or local anaesthesia) 5. Chronic pain syndromes: Patients with chronic pain syndromes (taking opioids, antidepressants, anticonvulsant agents) 6. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients; ascertained or presumptive hypersensitivity to the amide and ester-type anaesthetics 7. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; ascertained psychiatric diseases, sepsis, blood coagulation disorders, insulin dependent diabetes mellitus, terminal kidney failure 8. Medications: Medication known to interfere with the extent of regional blocks (see chloroprocaine and ropivacaine SmPCs) for 2 weeks before the start of the study. Hormonal contraceptives for females will be allowed 9. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study, calculated from the first day of the month following the last visit of the previous study 10. Drug, alcohol: history of drug or alcohol abuse 11. Pregnancy: missing or positive pregnancy test at screening, pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Non-inferiority evaluation of Test versus Reference product 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 ;Secondary Objective: Comparison between Test and Reference products in terms of the time to onset of sensory block [time to readiness for surgery], time to regression of sensory block, time to onset and regression of motor block, need for supplemental anaesthesia/analgesia and time to eligibility for home discharge; safety evaluation of the study treatments.;Primary end point(s): Proportion of patients with a successful block for distal upper limb surgeries, without any supplementation (i.e. no general anaesthesia or pre- and intra-operative systemic analgesia and no additional anaesthetic infiltration) in the first 45 min, calculated from the time of readiness for surgery (complete sensory block). ;Timepoint(s) of evaluation of this end point: Successful block is defined as: 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Sensory and motor blocks will be assessed every 5 min until the patient is ready for surgery. Then, blocked limbs will be evaluated as soon as possible after surgery (taking into consideration the end of the surgery procedures), then every 15 min for the first hour after surgery, every 30 min for the next 2 hours and then every hour until regression of surgical anaesthesia. Adverse Events will be evaluated throughout the study, neurological symptoms will also be evaluated through an interview using a specific questionnaire at final visit and at follow up.;Secondary end point(s): Efficacy end-points: - Time to onset of sensory block (corresponding to readiness for surgery), - Time to onset of motor block, - Time to regression of sensory block - Time to regression of motor block, - Time to administration of rescue anaesthesia or rescue analgesia, - Time to first post-operative analgesia, - Time to eligibility for home discharge. Safety end-points: Safety and general tolerability of the study treatments on the basis of treatment-emergent adverse events (TEAEs), neurological symptoms (e.g. paraesthesia, motor function problems and pain at the injection site), vital signs measurements (blood pressure, heart rate, oxygen saturation [SpO2]) and ECG recordings. | — |
Countries
Austria, Switzerland
Contacts
Public ContactStudy Management
CROSS Research S.A.
Outcome results
None listed