E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003008 |
E.1.2 | Term | Appendectomy |
|
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 |
Comparer les 2 groupes de patients (instillation de ropivacaine ou instillation de sérum physiologique) en terme de patient nécessitant la prescription d’antalgiques centraux (dose totale de tramadol ou de morphine) au cours de leur hospitalisation |
|
E.2.2 | Secondary objectives of the trial |
Comparer les groupes de patients en terme dedose totale d’analgésique (propacetamol et antalgiques centraux tels que tramadol ou morphine) reçu,d’intensité de la douleur postopératoire pendant l’hospitalisation,de fréquence des effets secondaires liés aux antalgiques,de délai de reprise de l’alimentation,de satisfaction du patient,de coût total en antalgiques. Comparer les groupes en terme de durée d’hospitalisation (sortie effective du patient et moment à partir duquel le patient est déclaré sortant) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Homme ou femme âgé de plus de 18 ans.Patient ayant été informé des objectifs et contraintes de l’étude et ayant donné son consentement par écrit.Patient devant bénéficier d'une chirurgie appendiculaire par voie de Mac Burney en urgence. |
|
E.4 | Principal exclusion criteria |
Patient refusant de signer le consentement, mineurs et majeurs sous tutelle.Patient ayant des antécédents de chirurgie abdominaleAllergie aux anesthésiques locaux |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Comparer les 2 groupes de patients (instillation de ropivacaine ou instillation de sérum physiologique) en terme de patient nécessitant la prescription d’antalgiques centraux (dose totale de tramadol ou de morphine) au cours de leur hospitalisation |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |