Pediatric patients undergoing surgery of flatfoot or inguinal hernia MedDRA version: 20.0 Level: LLT Classification code 10002325 Term: Anesthesia local System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Decelex
Pharmaceutical Form: Solution for injection
Trade Name: Ampres
Product Name: Chloroprocaine 2%
Pharmaceutical Form: Solution for injection
Sponsors
SINTETICA SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and femalepaediatric patients from birth to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. ASA > II patients 2. Preexistent infection at injection site; 3. Use of opioids, antidepressants, anticonvulsant, sulfonamide, vasopressors, ergot-type oxytocic drug and mixtures of local anaesthetics, antiarrhythmic drug class III, such as amiodarone, strong inhibitors of CYP1A2, such as fluvoxamine and enoxacin; 4. Use of medication(s) known to interfere with the extent of regional blocks for 2 weeks before the start of the study; 5. History of drug or alcohol abuse; 6. Sensitivity among the study medication active ingredient, the members of the PABA esters group and amides-type local anesthetic group; 7. Clinical history of allergy, hypersensitivity or intolerance to the study medication or other medications used during surgery; 8. Pregnancy and lactation: positive pregnancy test at screening (if applicable), pregnant or lactating (the pregnancy test will be performed to all fertile subset) 9. Participation in any other clinical study within the 3 months prior to the screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is the assessment of the efficacy of chloroprocaine 1% and 2%, administered by perineural, ultrasound-guided, injection in pediatric population for a successful peripheral nerve block (same volume ml/Kg) in terms of proportions of subjects not requiring rescue anesthesia during surgery.;Secondary Objective: •Time to onset of sensory block starting from completion of the Investigational Medicinal Products IMPs injection by the response to pinprick•time to onset of sensory block starting from completion of the IMPs injection•time to regression of motor block by standard Bromage scale, at the start of patient’s awakening, in case of calcaneo stop procedure•pain intensity assessed by the scales: COMFORT, FLACC, Wong-Baker•Time to eligibility for home discharge•if rescue anaesthesia (fentanyl) was required •time and dosage of rescue anaesthesia (fentanyl)•the general tolerability and safety assessed through summaries of adverse events•pain at injection site, neurological symptoms (such as: convulsions) and cardiac symptoms (such as bradycardia and heart failure etc.);Primary end point(s): The primary efficacy endpoint of the study will be represented by the overall proportion of patients, in each of the two dosage level groups, not requiring rescue anesthesia during surgery.;Timepoint(s) of evaluation of this end point: Day of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints: The secondary efficacy endpoints of the trial will be evaluated, unless otherwise specified, on the two dosage level groups separately and, in both the two dosage level groups, on the two surgical procedures. Secondary efficacy endpoints will be: 1 Proportion of patients, in both of the two dosage level groups, not requiring rescue anaesthesia (fentanyl) during the two surgical procedures separately; 2 Time to onset of sensory block, defined as the time period from completion of the injection (time 0 min) to the achievement of complete sensory block, assessed by pin-prick test associated with heart rate measurement, and evaluated for both surgeries; 3 Time to regression of motor block evaluated in ‘calcaneo stop’ surgery only and assessed by a grade I of the standard Bromage scale (i.e. free movement of legs and feet). This evaluation will be performed immediately after the awakening and it will be repeated 30 minutes, 1 hour, 2 hours and 3 hours after the first evaluation, as well as during the visit for discharge 4 Pain intensity evaluated five times in the first 3 hours after patient’s awakening and during the home discharge visit (V2). Post-surgery assessment will be performed immediately after the awakening and it will be repeated 30 minutes, 1 hour, 2 hours and 3 hours after the firstevaluation. The technique and appropriate scale for pain measurement are age-dependent therefore, different tools will have to be used for the evaluation: ? COMFORT scale for patients <2 months of age; ? FLACC scale for patients aged = 2 months = 6 years; ? Wong-Baker scale for patients over 6 years of age; 5 Time to eligibility for home discharge, defined as: “the time elapsed from completion of surgery to the time when criteria for discharge are met, regardless if the patient will be discharged from the hospital at a later time, according to the hospital procedures”. The criteria for discharge will be defined according wit | — |
Countries
Italy, Spain
Contacts
Public ContactClinical Operation
Link Neuroscience and Health Care srl - L.N.Age srl
Outcome results
None listed