Evaluating Chloroprocaine for Pediatric Anesthesia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial assesses the efficacy and safety of two concentrations of Chloroprocaine (1% and 2%) as a local anesthetic for pediatric patients undergoing inguinal hernia repair or flat foot surgery. It is a randomized, multi-center, double-blind trial designed to compare the effects of these two concentrations on pain management during and after surgery. The study is part of a broader Pediatric Investigational Plan aimed at obtaining marketing authorization for Chloroprocaine's use in children. The trial will involve a diverse group of pediatric patients to ensure comprehensive data collection on the anesthetic's performance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male and female paediatric patients from birth to \<18 years scheduled for:

   * Flat Foot surgery (6 to \<18 years; children and adolescents)planned for sciatic nerve block short-lasting anaesthesia,
   * inguinal hernia repair (28 day from birth to 6 years; 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.

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.

Where it's running

• Ospedale Infantile Santa Margherita di Torino Anestesia e Rianimazione Pediatrica
  Torino, Piemonte, Italy Recruiting
• Ospedale Pediatrico Giovanni XXIII
  Bari, Italy Recruiting
• Ospedale Pediatrico Bambin Gesù di Roma Dipartimento di Emergenza Accettazione (DEA) e A.R.C.O
  Roma, Lazio, Italy Active not recruiting
• Fondazione Policlinico Universitario Agostino Gemelli U.O.C. Anestesia delle Chirurgie Generali del Policlinico
  Roma, Lazio, Italy Active not recruiting
• Ospedale San Raffaele Anestesia e Rianimazione del distretto testacollo
  Milano, Lombardia, Italy Completed
• Ospedale Universitario Santa Maria della Misericordia S.C. di Anestesia e Rianimazione 2
  Perugia, Umbria, Italy Terminated

Study contacts

• Principal investigator: Valeria Mosetti, MD — Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
• Study coordinator: Anna Bulgheroni, Dr
• Email: abulgheroni@sintetica.com
• Phone: +41 91 640 42 50

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.