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

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.

Timeline

Start

2019-02-14

Primary completion

2025-10-17

Completion

2025-10-17

Drugs

Indications