Evaluating Chloroprocaine for Pediatric Anesthesia

Randomized, Multi-center, Double-blind, Two-armed, Parallel Active Groups, Prospective Trial, to Evaluate, in Pediatric Population, the Efficacy and Safety of Chloroprocaine 1% and 2% for Peripheral Nerve Block.

This study is testing two different strengths of Chloroprocaine to see which one works better for managing pain in kids having surgery for hernias or flat feet.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 174 (estimated)
• Ages: N/A to 17 Years
• Sex: All
• Sponsor: Sintetica SA (Industry-sponsored)
• Locations: 9 sites (Roma, Lazio and 8 other locations)
• Trial ID: NCT03918798 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include pediatric patients from birth to 18 years scheduled for flat foot surgery or inguinal hernia repair.

Not a fit: Patients with significant comorbidities or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective anesthesia option for pediatric patients, reducing the need for systemic opioids.

How similar studies have performed: Other studies have shown promising results with similar local anesthetic approaches in pediatric populations, indicating potential for success.

Eligibility criteria

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 this trial is running

Roma, Lazio and 8 other locations

• 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 Infantile Santa Margherita di Torino Anestesia e Rianimazione Pediatrica — Torino, Piemonte, Italy (Recruiting)
• Ospedale Universitario Santa Maria della Misericordia S.C. di Anestesia e Rianimazione 2 — Perugia, Umbria, Italy (Terminated)
• Ospedale Pediatrico Giovanni XXIII — Bari, Italy (Recruiting)
• ASST Gaetano Pini CTO — Milano, Italy (Terminated)
• Consorcio Hospital General Universitario De Valencia Cirugía Mayor Ambulatoria Y Cirugía General Y Del Aparato Digestivo — Valencia, Spain (Terminated)
• Hospital Universitario Y Politecnico La Fe Cirugía Pediátrica Avda. Fernando Abril — Valencia, Spain (Terminated)

Study contacts

• Principal investigator: Valeria Mosetti, MD — Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
• Study coordinator: Anna Bulgheroni, Dr

Conditions Hernia, Inguinal; Flat Foot; Surgery; Pediatric population; Peripheral nerve block