The Efficacy and Safety of Chloroprocaine 1% and 2% in Pediatric Population

NCT03918798 | Completed Phase 2 DMC

• 1 other identifier: CHL.2/04-2015
• Study Type: interventional
• Target: 164
• Locations: 2 countries
• Sites: 9

Brief Summary

Randomized, multi-center, double-blind, two-armed, parallel active groups, prospective trial to evaluate the efficacy and safety of local anesthetic Chloroprocaine at two different concentrations ( at 1% and 2%) in a pediatric population subjected to peripheral nerve block due to Inguinal hernia repair or Flat foot surgery. The present Protocol is part of an extensive Pediatric Investigational Plan (PIP) in the contest of the marketing authorization application of chloroprocaine use for perineural block. The PDCO has adopted a positive opinion.

Conditions

Hernia, Inguinal; Flat Foot

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall proportion of patients, in each of the two dosage level groups, not requiring rescue anesthesia during surgery.

  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.

  Visit 2 (Day 1; surgery/discharge)

Secondary Outcomes (1)

• Proportion of patients, in both of the two dosage level groups, not requiring rescue anaesthesia (fentanyl) during the two surgical procedures separately

  Visit 2 (Day 1; surgery/discharge); FU phone call I( 24 hrs from Visit 2); FU phone call II (7 days from Visit 2)

Study Arms (2)

Chloroprocaine 1%

EXPERIMENTAL

All the eligible patients will be administrated by Chloroprocaine 1 % according to the randomization criteria.

Drug: Chloroprocaine 1% Injectable Solution

Chloroprocaine 2%

EXPERIMENTAL

All the eligible patients will be administrated by Chloroprocaine 2 % according to the randomization criteria.

Drug: Chloroprocaine 2% Injectable Solution

Interventions

Chloroprocaine 1% Injectable Solution DRUG

All the eligible patients will be administrated by Chloroprocaine 1 % according to the randomization criteria.

Also known as: ARM 1

Chloroprocaine 1%

Chloroprocaine 2% Injectable Solution DRUG

All the eligible patients will be administrated by Chloroprocaine 1 % according to the randomization criteria.

Also known as: ARM 2

Chloroprocaine 2%

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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;
• 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);
• ASA I and ASA II patients;
• 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;
• Willing and able to give additional written informed consent by itself, in case of children and adolescents, in addition to parents/tutor;
• Willing and able, in case of children and adolescents, to comply with the study requirements on their behalf.

You may not qualify if:

• ASA \> II patients;
• Preexistent infection at injection site;
• 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;
• Use of medication(s) known to interfere with the extent of regional blocks for 2 weeks before the start of the study;
• History of drug or alcohol abuse;
• Sensitivity among the study medication active ingredient, the members of the PABA esters group and amides-type local anesthetic group;
• Clinical history of allergy, hypersensitivity or intolerance to the study medication or other medications used during surgery;
• Pregnancy and lactation: positive pregnancy test at screening (if applicable), pregnant or lactating (the pregnancy test will be performed to all fertile subset);
• Participation in any other clinical study within the 3 months prior to the screening.

Sponsors & Collaborators

• Sintetica SA: lead

Study Sites (9)

Ospedale Pediatrico Giovanni XXIII

Bari, Italy, 70126, Italy

Location

ASST Gaetano Pini CTO

Milan, Italy, 20122, Italy

Location

Ospedale Pediatrico Bambin Gesù di Roma Dipartimento di Emergenza Accettazione (DEA) e A.R.C.O

Rome, Lazio, 00165, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli U.O.C. Anestesia delle Chirurgie Generali del Policlinico

Rome, Lazio, 00168, Italy

Location

Ospedale San Raffaele Anestesia e Rianimazione del distretto testacollo

Milan, Lombardy, 20132, Italy

Location

Ospedale Infantile Santa Margherita di Torino Anestesia e Rianimazione Pediatrica

Turin, Piedmont, 10126, Italy

Location

Ospedale Universitario Santa Maria della Misericordia S.C. di Anestesia e Rianimazione 2

Perugia, Umbria, 06129, Italy

Location

Consorcio Hospital General Universitario De Valencia Cirugía Mayor Ambulatoria Y Cirugía General Y Del Aparato Digestivo

Valencia, Valencia, 46014, Spain

Location

Hospital Universitario Y Politecnico La Fe Cirugía Pediátrica Avda. Fernando Abril

Valencia, Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Hernia, Inguinal; Flatfoot

Interventions

chloroprocaine

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Valeria Mosetti, MD

  Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: April 18, 2019
• Study Start: February 14, 2019
• Primary Completion: October 17, 2025
• Study Completion: October 17, 2025
• Last Updated: March 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); IT (7)