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Hernia, InguinalPhase 2NCT03918798

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

A Phase 2 study testing Chloroprocaine 1% Injectable Solution and Chloroprocaine 2% Injectable Solution in people with Hernia, Inguinal and Flat Foot, run by Sintetica SA at 9 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages Up to 17 years
Conditions the study is for
Hernia, Inguinal, Flat Foot
What is being tested?
Chloroprocaine 1% Injectable Solution and Chloroprocaine 2% Injectable Solution
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
164 participants
Where
9 sitesin 2 countries
Study dates
14 Feb 2019to 17 Oct 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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;
  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

9 sites in 2 countries.

9 sites in 2 countries

Italy7 sites

  • Ospedale Pediatrico Giovanni XXIII

    Bari, Italy, 70126

  • ASST Gaetano Pini CTO

    Milan, Italy, 20122

  • Ospedale San Raffaele Anestesia e Rianimazione del distretto testacollo

    Milan, Lombardy, 20132

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

    Perugia, Umbria, 06129

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

    Rome, Lazio, 00165

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

    Rome, Lazio, 00168

  • Ospedale Infantile Santa Margherita di Torino Anestesia e Rianimazione Pediatrica

    Turin, Piedmont, 10126

Other trials in Italy

Spain2 sites

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

    Valencia, Valencia, 46014

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

    Valencia, Valencia, 46026

Other trials in Spain

About this study

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.

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.

Read the 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.

Being tested
Chloroprocaine 1% Injectable Solution, Chloroprocaine 2% Injectable Solution
Keywords
Surgery, Hernia, Inguinal, Flat Foot, Pediatric population, Peripheral nerve block
Medical subject headings
Hernia, Inguinal, Flatfoot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chloroprocaine 1% Injectable SolutionDrug

    Also called ARM 1

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

  • Chloroprocaine 2% Injectable SolutionDrug

    Also called ARM 2

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

Study groups in NCT03918798
Study groupRoleWhat they receive
Chloroprocaine 1%ExperimentalAll the eligible patients will be administrated by Chloroprocaine 1 % according to the randomization criteria.
Receives: Drug: Chloroprocaine 1% Injectable Solution
Chloroprocaine 2%ExperimentalAll the eligible patients will be administrated by Chloroprocaine 2 % according to the randomization criteria.
Receives: Drug: Chloroprocaine 2% Injectable Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Visit 2 (Day 1; surgery/discharge)

Secondary outcomes (1)

  1. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2019
  2. Study start14 Feb 2019
  3. Primary completion17 Oct 2025
  4. Study completion17 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03918798
Sponsor's protocol ID
CHL.2/04-2015
Status last verified
Jan 2026
First submitted
20 Mar 2019
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It is not yet known if there will be a plan to make IPD available.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chloroprocaine 1% Injectable Solution and Chloroprocaine 2% Injectable Solution in people with Hernia, Inguinal and Flat Foot, run by Sintetica SA at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03918798.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.

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