The Efficacy and Safety of Chloroprocaine 1% and 2% in Pediatric Population
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03918798 |
|
Recruitment Status :
Recruiting
First Posted : April 18, 2019
Last Update Posted : January 18, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hernia, Inguinal Flat Foot | Drug: Chloroprocaine 1% Injectable Solution Drug: Chloroprocaine 2% Injectable Solution | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 174 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Supportive Care |
| 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. |
| Actual Study Start Date : | February 14, 2019 |
| Estimated Primary Completion Date : | June 30, 2023 |
| Estimated Study Completion Date : | June 30, 2023 |
| Arm | Intervention/treatment |
|---|---|
|
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 Name: 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 Name: ARM 2 |
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | up to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918798
| Contact: Elisabetta Donati, Corp Dir. | +41 (0)91 640 42 50 | corporate_clinical_rd@sintetica.com | |
| Contact: Anna Bulgheroni, Manager | +41 (0)91 640 42 50 | corporate_clinical_rd@sintetica.com |
| Italy | |
| Ospedale Pediatrico Bambin Gesù di Roma Dipartimento di Emergenza Accettazione (DEA) e A.R.C.O | Recruiting |
| Roma, Lazio, Italy, 00165 | |
| 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: Liliana Solazzi, MD liliana.sollazzi@unicatt.it | |
| Contact: Francesca Vitale, MD francesca.vitale@policlinicogemelli.it | |
| Ospedale San Raffaele Anestesia e Rianimazione del distretto testacollo | Completed |
| Milano, Lombardia, Italy, 20132 | |
| Ospedale Infantile Santa Margherita di Torino Anestesia e Rianimazione Pediatrica | Recruiting |
| Torino, Piemonte, Italy, 10126 | |
| Contact: Valeria Mosetti, MD valeriamossetti@gmail.com | |
| Ospedale Universitario Santa Maria della Misericordia S.C. di Anestesia e Rianimazione 2 | Terminated |
| Perugia, Umbria, Italy, 06129 | |
| Ospedale Pediatrico Giovanni XXIII | Not yet recruiting |
| Bari, Italy, 70126 | |
| Contact: Leonardo MiIlella, MD | |
| ASST Gaetano Pini CTO | Not yet recruiting |
| Milano, Italy, 20122 | |
| Contact: Paolo Grossi, MD | |
| Spain | |
| Consorcio Hospital General Universitario De Valencia Cirugía Mayor Ambulatoria Y Cirugía General Y Del Aparato Digestivo | Terminated |
| Valencia, Spain, 46014 | |
| Hospital Universitario Y Politecnico La Fe Cirugía Pediátrica Avda. Fernando Abril | Terminated |
| Valencia, Spain, 46026 | |
| Principal Investigator: | Valeria Mosetti, MD | Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna |
Documents provided by Sintetica SA:
| Responsible Party: | Sintetica SA |
| ClinicalTrials.gov Identifier: | NCT03918798 |
| Other Study ID Numbers: |
CHL.2/04-2015 |
| First Posted: | April 18, 2019 Key Record Dates |
| Last Update Posted: | January 18, 2023 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | It is not yet known if there will be a plan to make IPD available. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Surgery Hernia, Inguinal Flat Foot Pediatric population Peripheral nerve block |
|
Flatfoot Hernia Hernia, Inguinal Pathological Conditions, Anatomical Hernia, Abdominal Talipes Foot Deformities, Acquired Foot Deformities Musculoskeletal Diseases Foot Deformities, Congenital Lower Extremity Deformities, Congenital Limb Deformities, Congenital |
Musculoskeletal Abnormalities Congenital Abnormalities Chloroprocaine Procaine Pharmaceutical Solutions Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |