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Study to evaluate the efficacy and safety of a local anesthetic used in flat foot or inguinal hernia interventions at two different concentrations (1% and 2%) given to two distinct groups of patients
EU CTIS ID: 2024-518179-76-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and femalepaediatric patients aged 28 days 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 (28 days from birth to 6 years; newborn infants, infantstoddlers 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) or 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.
You likely can't join if
- 1. ASA > II patients 2. Preexistent infection at injection site; 3. Use of opioids, antidepressants, anticonvulsant, sulfonamide, vasopressors, ergottype 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 10. Patient’s weight > 72 Kg.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.