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

NCT ID: NCT03918798

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-14
• Study Completion Date: 2024-12-30

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.

Detailed Description

Randomized, multi-center, double-blind, two-armed, parallel active groups, prospective trial, to evaluate, in pediatric population undergoing Flat Foot surgery or Inguinal hernia repair, the efficacy and safety of chloroprocaine 1% and 2% for peripheral nerve block (PNB) based on concentration-response relationships. The present protocol is part of an extensive Pediatric Investigational Plan (PIP) which has been submitted to the Paediatric Committee (PDCO) of the European Medicine Agency (EMA)in the contest of the marketing authorization application of chloroprocaine use for perineural block. The PDCO has adopted a positive opinion on both the PIP and the present clinical protocol.

Chloroprocaine Hydrochloride 1% Sintetica is currently marketed in 9 European countries as intrathecal (spinal) anesthetic in adults where the planned surgical procedure is not expected to exceed 40 minutes. Since 2015, the Marketing Authorization in Switzerland has been extended to chloroprocaine HCl 20 mg/mL and 30 mg/mL solutions for injection, for local anesthesia by infiltration, for PNB and epidural block, respectively. Regional analgesia, and specifically PNB, is an acceptable means of providing intraoperative anesthesia and postoperative analgesia in neonates, infants, and children while decreasing the use of systemic opioids and avoiding opioid-related adverse effects. With the advent of ultrasound and improvements in equipment in the last decade, the utilization of PNB in children has increased tremendously.

Flat Foot and inguinal hernia repair have been considered the ideal surgeries for testing the clinical efficacy and safety of chloroprocaine since they are short procedures with low postoperative pain that only require a short- to intermediate-acting agent. The study consists of a treatment period of 1 day and of a single perineural injection, administered through ultrasound-guided technique in order to avoid the risk of chloroprocaine IV injection. A total of 174 (87 per treatment group, allocated to 1% or 2% arm in a ratio of 1:1) male and female paediatric patients (age range from birth to <18 years) undergoing Flat Foot surgery or Inguinal hernia repair, planned for peripheral nerve block anaesthesia and equally distributed within the two surgical procedures.

Conditions

Hernia, Inguinal; Flat Foot

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Chloroprocaine 1%

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

Group Type: EXPERIMENTAL

Chloroprocaine 1% Injectable Solution

Intervention Type: DRUG

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

Chloroprocaine 2%

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

Group Type: EXPERIMENTAL

Chloroprocaine 2% Injectable Solution

Intervention Type: DRUG

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

Interventions

Chloroprocaine 1% Injectable Solution

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

Intervention Type: DRUG

Chloroprocaine 2% Injectable Solution

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

Intervention Type: DRUG

Other Intervention Names

ARM 1; ARM 2

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.

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sintetica SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valeria Mosetti, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Locations

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

Rome, Lazio, Italy

Site Status: ACTIVE_NOT_RECRUITING

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

Rome, Lazio, Italy

Site Status: ACTIVE_NOT_RECRUITING

Ospedale San Raffaele Anestesia e Rianimazione del distretto testacollo

Milan, Lombardy, Italy

Site Status: COMPLETED

Ospedale Infantile Santa Margherita di Torino Anestesia e Rianimazione Pediatrica

Turin, Piedmont, Italy

Site Status: RECRUITING

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

Perugia, Umbria, Italy

Site Status: TERMINATED

Ospedale Pediatrico Giovanni XXIII

Bari, , Italy

Site Status: RECRUITING

ASST Gaetano Pini CTO

Milan, , Italy

Site Status: TERMINATED

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

Valencia, , Spain

Site Status: TERMINATED

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

Valencia, , Spain

Site Status: TERMINATED

Countries

Italy; Spain

Central Contacts

Anna Bulgheroni, Dr

Role: CONTACT

abulgheroni@sintetica.com

+41 91 640 42 50 ext. 2396

Anna Guaita, PhD

Role: CONTACT

aguaita@sintetica.com

Facility Contacts

Valeria Mosetti, MD

Role: primary

valeriamossetti@gmail.com

Salvatore Grasso, MD

Role: primary

salvatore.grasso@uniba.it

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CHL.2/04-2015

Identifier Type: -

Identifier Source: org_study_id