History of Changes for Study: NCT03918798

The Efficacy and Safety of Chloroprocaine 1% and 2% in Pediatric Population Undergoing'Calcaneo Stop' Surgery or Inguinal Hernia Repair

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Study Record Versions

Version	Submitted Date	Changes
1	April 16, 2019	None (earliest Version on record)
2	October 24, 2019	Recruitment Status, Study Status and Contacts/Locations
3	March 19, 2021	Study Status
4	April 19, 2021	Study Status
5	April 19, 2021	Study Identification and Study Status
6	August 30, 2021	Study Status
7	February 2, 2022	Study Status
8	May 19, 2022	Study Status
9	September 27, 2022	Study Status
10	January 16, 2023	Contacts/Locations and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CHL.2/04-2015
Brief Title:	The Efficacy and Safety of Chloroprocaine 1% and 2% in Pediatric Population Undergoing'Calcaneo Stop' Surgery or Inguinal Hernia Repair
Official Title:	Randomized, Multi-center, Double-blind, Two-armed, Parallel Active Groups, Prospective Trial, to Evaluate, in Pediatric Population Undergoing 'Calcaneo Stop' Surgery or Inguinal Hernia Repair, the Efficacy and Safety of Chloroprocaine 1% and 2% for Peripheral Nerve Block Based on Concentration-Response Relationships.
Secondary IDs:

Study Status


Record Verification:	October 2019
Overall Status:	Recruiting
Study Start:	February 14, 2019
Primary Completion:	March 7, 2021 [Anticipated]
Study Completion:	March 14, 2021 [Anticipated]

First Submitted:	March 20, 2019
First Submitted that Met QC Criteria:	April 16, 2019
First Posted:	April 18, 2019 [Actual]

Last Update Submitted that Met QC Criteria:	October 24, 2019
Last Update Posted:	October 25, 2019 [Actual]

Sponsor/Collaborators


Sponsor:	Sintetica SA
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

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.

Conditions


Conditions:	Hernia, Inguinal Flat Foot
Keywords:	Surgery Hernia, Inguinal Flat Foot Pediatric population Peripheral nerve block

Study Design


Study Type:	Interventional
Primary Purpose:	Supportive Care
Study Phase:	Phase 2
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Double (Participant, Investigator)
Allocation:	Randomized
Enrollment:	174 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Chloroprocaine 1% All the eligible patients will be administrated by Chloroprocaine 1 % according to the randomization criteria.	Drug: Chloroprocaine 1% Injectable Solution All the eligible patients will be administrated by Chloroprocaine 1 % according to the randomization criteria. Other Names: ARM 1
Experimental: Chloroprocaine 2% All the eligible patients will be administrated by Chloroprocaine 2 % 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. Other Names: ARM 2

Outcome Measures


Primary Outcome Measures:
1.	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) ] 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:
1.	Proportion of patients, in both of the two dosage level groups, not requiring rescue anaesthesia (fentanyl) during the two surgical procedures separately [ 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) ] 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

Eligibility


Minimum Age:
Maximum Age:	17 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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.

Contacts/Locations


Central Contact Person:	Elisabetta Donati, Corp Dir. Telephone: +41 (0)91 640 42 50 Email: corporate_clinical_rd@sintetica.com
Central Contact Backup:	Barbara Piccagli, Manager Telephone: +41 (0)91 640 42 50 Email: corporate_clinical_rd@sintetica.com
Study Officials:	Giorgio Ivani, MD Principal Investigator Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Locations:	Italy, Lazio
	Ospedale Pediatrico Bambin Gesù di Roma Dipartimento di Emergenza Accettazione (DEA) e A.R.C.O [Not yet recruiting] Roma, Lazio, Italy, 00165 Contact:Contact: Alessandra Di Palma, MD alessandra.dipalma@opbg.net
	Fondazione Policlinico Universitario Agostino Gemelli U.O.C. Anestesia delle Chirurgie Generali del Policlinico [Recruiting] Roma, Lazio, Italy, 00168 Contact:Contact: Liliana Solazzi, MD liliana.sollazzi@unicatt.it Contact:Contact: Francesca Vitale, MD francesca.vitale@policlinicogemelli.it
	Italy, Lombardia
	Ospedale San Raffaele Anestesia e Rianimazione del distretto testacollo [Enrolling by invitation] Milano, Lombardia, Italy, 20132
	Italy, Piemonte
	Ospedale Infantile Santa Margherita di Torino Anestesia e Rianimazione Pediatrica [Recruiting] Torino, Piemonte, Italy, 10126 Contact:Contact: Giorgio Ivani, MD givani@cittadellasalute.to.it Contact:Contact: Valeria Mossetti, MD valeriamossetti@gmail.com
	Italy, Umbria
	Ospedale Universitario Santa Maria della Misericordia S.C. di Anestesia e Rianimazione 2 [Not yet recruiting] Perugia, Umbria, Italy, 06129 Contact:Contact: Vito Peduto, MD vito.peduto@unipg.it Contact:Contact: Simonetta Tesoro, MD simonettatesoro@gmail.com
	Spain
	Consorcio Hospital General Universitario De Valencia Cirugía Mayor Ambulatoria Y Cirugía General Y Del Aparato Digestivo [Not yet recruiting] Valencia, Spain, 46014 Contact:Contact: CRISTÓBAL ZARAGOZA FERNÁNDEZ, MD Zaragoza_cri@gva.es
	Hospital Universitario Y Politecnico La Fe Cirugía Pediátrica Avda. Fernando Abril [Not yet recruiting] Valencia, Spain, 46026 Contact:Contact: JAVIER LLUNA GONZÁLEZ, MD Lluna_jav@gva.es

IPDSharing


Plan to Share IPD:	No It is not yet known if there will be a plan to make IPD available.

References


Citations:
Links:
Available IPD/Information:

Document Section


	Study Protocol Document Date: June 14, 2018 Uploaded: 03/14/2019 05:53 File Name: Prot_000.pdf
	Informed Consent Form Document Date: July 2, 2018 Uploaded: 03/20/2019 07:04 File Name: ICF_001.pdf
	Statistical Analysis Plan Document Date: July 25, 2018 Uploaded: 04/16/2019 08:47 File Name: SAP_002.pdf