Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New numbing drug shows promise for Kids' surgery pain

NCT ID NCT03918798

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two different strengths of a numbing medicine called chloroprocaine in 164 children having hernia repair or flat foot surgery. The goal was to see if the medicine could block pain during the operation without needing extra painkillers. The results help doctors choose the best dose for children.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

164 people

The number who actually took part.

Started

Feb 2019

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Flat foot are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

flatfoot Hernia, Inguinal

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • ASST Gaetano Pini CTO

    Milan, Italy, 20122, Italy

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

    Valencia, Valencia, 46014, Spain

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

    Rome, Lazio, 00168, Italy

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

    Valencia, Valencia, 46026, Spain

  • Ospedale Infantile Santa Margherita di Torino Anestesia e Rianimazione Pediatrica

    Turin, Piedmont, 10126, Italy

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

    Rome, Lazio, 00165, Italy

  • Ospedale Pediatrico Giovanni XXIII

    Bari, Italy, 70126, Italy

  • Ospedale San Raffaele Anestesia e Rianimazione del distretto testacollo

    Milan, Lombardy, 20132, Italy

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

    Perugia, Umbria, 06129, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.