Study to evaluate in children under 18 years of age the efficacy and safety of a local anesthetic used in flat foot interventions or inguinal hernia at two different concentrations (1% and 2%) administered to two separate groups of patients.

Phase 1

• Conditions: Pediatric patients undergoing surgery of flatfoot or inguinal hernia; MedDRA version: 20.0Level: LLTClassification code 10002325Term: Anesthesia localSystem Organ Class: 100000004865; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2018-000656-18-ES
• Lead Sponsor: SINTETICA SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-25
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

1.Male and femalepaediatric patients from birth to <18 years scheduled for:
-'calcaneo stop' surgery (6 to <18 years; children and adolescents)planned for sciatic nerve block short-lasting anaesthesia,
-inguinal hernia repair (0 to 6 years; newborn infants, infants-toddlers and children)planned for ilioinguinal/iliohypogastric block short-lasting anaesthesia;
2.Normally active and otherwise judged to be in good health on the basis of medical history, physical examination, with normal lean body mass (BMI18,5 – 24,9 Kg/m2 inclusive) and normal body development (normal weight and height according to local paediatric Height and Weight Chart);
3.ASA I and ASA II patients
4.Written informed consent provided by parents/tutor, willing and able to understand the purpose of the study, including possible risks and side effects, and willing and able to comply, on their behalf and of the minor, with the study requirements.
5.Willing and able to give additional written informed consent by itself, in case of children and adolescents, in addition to parents/tutor.
6.Willing and able, in case of children and adolescents, to comply with the study requirements on their behalf.
Are the trial subjects under 18? yes
Number of subjects for this age range: 174
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified