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

Primary Purpose

Hernia, Inguinal, Flat Foot

Status

Recruiting

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Chloroprocaine 1% Injectable Solution

Chloroprocaine 2% Injectable Solution

About this trial

This is an interventional supportive care trial for Hernia, Inguinal focused on measuring Surgery, Hernia, Inguinal, Flat Foot, Pediatric population, Peripheral nerve block

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 (0 to 6 years; newborn infants, 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.

Exclusion Criteria:

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.

Sites / Locations

Ospedale Pediatrico Bambin Gesù di Roma Dipartimento di Emergenza Accettazione (DEA) e A.R.C.ORecruiting
Fondazione Policlinico Universitario Agostino Gemelli U.O.C. Anestesia delle Chirurgie Generali del PoliclinicoRecruiting
Ospedale San Raffaele Anestesia e Rianimazione del distretto testacollo
Ospedale Infantile Santa Margherita di Torino Anestesia e Rianimazione PediatricaRecruiting
Ospedale Universitario Santa Maria della Misericordia S.C. di Anestesia e Rianimazione 2
Ospedale Pediatrico Giovanni XXIII
ASST Gaetano Pini CTO
Consorcio Hospital General Universitario De Valencia Cirugía Mayor Ambulatoria Y Cirugía General Y Del Aparato Digestivo
Hospital Universitario Y Politecnico La Fe Cirugía Pediátrica Avda. Fernando Abril

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Chloroprocaine 1%

Chloroprocaine 2%

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Proportion of patients, in both of the two dosage level groups, not requiring rescue anaesthesia (fentanyl) during the two surgical procedures separately; Time to onset of sensory block, defined as the time period from completion of the injection (time 0 min) to the achievement of complete sensory block, assessed by pinprick test associated with heart rate measurement, and evaluated for both surgeries; Time to regression of motor block evaluated in 'calcaneo stop' surgery only and assessed by a grade I of the standard Bromage scale (i.e. free movement of legs and feet). Pain intensity evaluated five times in the first 3 hours after patient's awakening andduring the home discharge visit (V2). The technique and appropriate scale for pain measurement are age-dependent therefore, different tools will have to be used for the evaluation: COMFORT scale for patients <2 months of age; FLACC scale for patients aged _ 2 months _ 6 years; Wong-Baker scale for patients over 6 years of age

Full Information

NCT ID

NCT03918798

First Posted

March 20, 2019

Last Updated

July 4, 2023

Sponsor

Sintetica SA

1. Study Identification

Unique Protocol Identification Number

NCT03918798

Brief Title

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

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 14, 2019 (Actual)

Primary Completion Date

April 30, 2024 (Anticipated)

Study Completion Date

April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sintetica SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hernia, Inguinal, Flat Foot

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

174 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chloroprocaine 1%

Arm Type

Experimental

Arm Description

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

Arm Title

Chloroprocaine 2%

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Chloroprocaine 1% Injectable Solution

Other Intervention Name(s)

ARM 1

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Chloroprocaine 2% Injectable Solution

Other Intervention Name(s)

ARM 2

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Visit 2 (Day 1; surgery/discharge)

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

10. Eligibility

Sex

All

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 (0 to 6 years; newborn infants, 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Elisabetta Donati, Corp Dir.

Phone

+41 (0)91 640 42 50

corporate_clinical_rd@sintetica.com

First Name & Middle Initial & Last Name or Official Title & Degree

Anna Bulgheroni, Manager

Phone

+41 (0)91 640 42 50

corporate_clinical_rd@sintetica.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Valeria Mosetti, MD

Organizational Affiliation

Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Roma

State/Province

Lazio

ZIP/Postal Code

00165

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alessandra Di Palma, MD

alessandra.dipalma@opbg.net

Facility Name

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

City

Roma

State/Province

Lazio

ZIP/Postal Code

00168

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Liliana Solazzi, MD

liliana.sollazzi@unicatt.it

First Name & Middle Initial & Last Name & Degree

Francesca Vitale, MD

francesca.vitale@policlinicogemelli.it

Facility Name

Ospedale San Raffaele Anestesia e Rianimazione del distretto testacollo

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20132

Country

Italy

Individual Site Status

Completed

Facility Name

Ospedale Infantile Santa Margherita di Torino Anestesia e Rianimazione Pediatrica

City

Torino

State/Province

Piemonte

ZIP/Postal Code

10126

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Valeria Mosetti, MD

valeriamossetti@gmail.com

Facility Name

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

City

Perugia

State/Province

Umbria

ZIP/Postal Code

06129

Country

Italy

Individual Site Status

Terminated

Facility Name

Ospedale Pediatrico Giovanni XXIII

City

Bari

ZIP/Postal Code

70126

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Leonardo MiIlella, MD

Facility Name

ASST Gaetano Pini CTO

City

Milano

ZIP/Postal Code

20122

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paolo Grossi, MD

Facility Name

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

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Individual Site Status

Terminated

Facility Name

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

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Individual Site Status

Terminated

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

It is not yet known if there will be a plan to make IPD available.

Learn more about this trial

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

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