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

NCT03918798 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2026-03-23

No results posted yet for this study

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

Interventions

DRUG

Chloroprocaine 1% Injectable Solution

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

DRUG

Chloroprocaine 2% Injectable Solution

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

Sponsors & Collaborators

  • Sintetica SA

    lead INDUSTRY

Principal Investigators

  • Valeria Mosetti, MD · Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-14
Primary Completion
2025-10-17
Completion
2025-10-17

Countries

  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03918798 on ClinicalTrials.gov