E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
PATHOLOGIE CHIRURGICALE DE LAJAMBE OU DU PIED |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Décrire les caractéristiques pharmacocinétiques de la lévobupivacaïne chez l’enfant, en utilisant les principes de la modélisation par population, après bloc périphérique |
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E.2.2 | Secondary objectives of the trial |
D’évaluer l’efficacité analgésique per et post opératoire de la Chirocaine® et d’en évaluer la sécurité en faisant un inventaire des effets secondaires rencontrés. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Pathologie chirurgicale de la jambe ou du pied avec garrot pneumatique de cuisse - Age : compris entre 6 mois et 12 ans - Statut ASA I ou II.
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E.4 | Principal exclusion criteria |
- Geste chirurgical bilatéral ou unilatéral réalisé sans garrot pneumatique - Infection cutanée au point de ponction - Trouble clinique de la coagulation - Allergie documentée aux anesthésiques locaux de classe amino-amide - Pathologie neurologique évolutive du membre opéré - Insuffisance rénale, respiratoire, cardiaque ou hépatique.
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E.5 End points |
E.5.1 | Primary end point(s) |
Le produit étudié (lévobupivacaïne) est utilisé en pratique quotidienne lors des abords périduraux chez l’enfant. Peu d’études décrivent son usage après blocs périphériques en pédiatrie. Le but de ce travail est de décrire les caractéristiques pharmacocinétiques de la lévobupivacaïne après bloc périphérique en utilisant le principe de la pharmacologie de population, ceci permettant de réaliser moins de prélèvements sanguins par malades. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |