E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
surgical patient |
paziente chirurgico |
|
E.1.1.1 | Medical condition in easily understood language |
patient undergoing abdominal surgery |
paziente che si sottopone ad intervento di chirurgia addominale |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10017947 |
E.1.2 | Term | Gastrointestinal disorders |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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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 |
evaluation of premedication with sub-lingual morphine on post-operative pain control following Pre-emptive Analgesia |
valutazione della efficacia della premedicazione con morfina solfato sub-linguale per il controllo del dolore acuto post-operatorio secondo la definizione della Pre-Emptive Analgesia |
|
E.2.2 | Secondary objectives of the trial |
1. reduction of consumption of analgesic drugs in post-operative period 2 reduction of surgical stress response (inflammatory response, cortisol plasmatic concentration, resistence to insulin) 3. faster mobilization of patient (reduction of hosptial lenght stay) |
1. ridurre il consumo dei farmaci analgesici nel periodo post-operatorio 2. ridurre la risposta allo stress chirurgico (risposta infiammatoria, livello di cortisolo e insulinoresistenza) 3. permettere la mobilizzazione precode del paziente (riduzione dei tempi di degenza ospedaliera) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- informed consent; - age between 18 and 80 y.o.; - ASA class I and II; - elective surgical operation, with length less than 6 hours |
- consenso informato; - eta' compresa tra 18 e 80 anni; - classe ASA I e II; - intervento chirugico eseguito in elezione, di durata inferiore a 6 ore |
|
E.4 | Principal exclusion criteria |
- age less than 18 yo - ASA class IIi and IV - emergency surgical operation - antidepressive drugs - chronic renal failure (dyalis or creatinine more than 2 mg/dl) - morphine ipersensivity -pregancy and nursing - history of abuse of alcohol or delirium tremens - seizure history - chronic respiratory failure (PaO2 less 60 mmHg or PaCO2 more than 60 mmHg) - Severe hepatic failure (Child Pugh class III and IV) |
- eta' inferiore a 18 anni; - classe ASA III e IV; - intervento chirugico in emergenza e urgenza; - utilizzo di farmaci antidepressivi; - insufficienza renale documentata (pazienti sottoposti a terapia renale sostitutiva o creatininemia superiore o pari a 2 mg/dl) - ipersensibilita' nota verso la morfina; - gravidanza e allattamento; - alcolismo acuto e delirium tremens; - stati convulsivi (assenze, crisi di grande e/o piccolo male epilettico); - insuficienza respiratoria (PA02 minore o uguale a 60 mm Hg e/o PACO2 maggiore o uguale a 60 mm Hg); - insufficienza epatica grave (Child Pugh III e IV) |
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E.5 End points |
E.5.1 | Primary end point(s) |
- reduction of post-operative pain of 50% in patient premedicated with sub-lingual morphine (static and dynamic VAS less than 30) in videolaparoscopic and open surgery |
- riduzione del dolore post-operatorio del 50% nei soggetti trattati con morfina solfato sublinguale rispetto ai soggetti trattati con Midazolam sublinguale (viene considerata come soglia del dolore una VAS statica e dinamica > 30) sia nella modalita' open che VL |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- reduction of IVPCA administered doses and failed doses of 40% in patient premedicated with sub-lingual morphine -reduction of morphine consumption of 40% with IVPCA in patient premedicated with sub-lingual morphine - reduction of aceatminophen rescue dose in patient premedicated with sub-lingual morphine |
- riduzione del 40% del numero delle chiamate e dei tentativi falliti registrati dal dispositivo del PCA nei soggetti trattati con morfina solfato sublinguale; - riduzione del 40% della somministrazione di morifna nelle 48 h successive all'intervento erogata con pCA nei soggetti trattati con morfina solfato sublinguale; - riduzione della necessita' di dose aggiuntiva con paracetamolo nei pz premedicati con morfina solfato nei soggetti trattati con morfina solfato sublinguale |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
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 | Yes |
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 | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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 | No |
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
|
Treatment stops after 48 hours from the operation and osservation stops at hospital dimission |
Il trattamento termina dopo 48 ore dall'operazione e l'osservazione termina al momento della dimissione dall'ospedale |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | 0 |