New numbing drug shows promise for Kids' surgery pain
NCT ID NCT03918798
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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164 people
The number who actually took part.
- Started
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Feb 2019
- Finished
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Oct 2025
- Lead sponsor
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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
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Up to 17 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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ASST Gaetano Pini CTO
Milan, Italy, 20122, Italy
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Consorcio Hospital General Universitario De Valencia Cirugía Mayor Ambulatoria Y Cirugía General Y Del Aparato Digestivo
Valencia, Valencia, 46014, Spain
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Fondazione Policlinico Universitario Agostino Gemelli U.O.C. Anestesia delle Chirurgie Generali del Policlinico
Rome, Lazio, 00168, Italy
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Hospital Universitario Y Politecnico La Fe Cirugía Pediátrica Avda. Fernando Abril
Valencia, Valencia, 46026, Spain
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Ospedale Infantile Santa Margherita di Torino Anestesia e Rianimazione Pediatrica
Turin, Piedmont, 10126, Italy
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Ospedale Pediatrico Bambin Gesù di Roma Dipartimento di Emergenza Accettazione (DEA) e A.R.C.O
Rome, Lazio, 00165, Italy
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Ospedale Pediatrico Giovanni XXIII
Bari, Italy, 70126, Italy
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Ospedale San Raffaele Anestesia e Rianimazione del distretto testacollo
Milan, Lombardy, 20132, Italy
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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.
- Smartphone Follow-Up could replace hospital stays after common surgeries
- Could a sock fix flat feet? new trial tests built-in insoles for kids
- New study tests if natural mesh can prevent Long-Term pain after hernia surgery
- Custom 3D-Printed insoles put to the test: do they really comfort your feet?
- Does extra numbing improve hernia surgery recovery?
- Robot vs. laparoscope: which hernia surgery is better?