E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Inguinal hernia liable to ambulatory surgery |
Hernia inguinal susceptible de cirugía ambulatoria |
|
E.1.1.1 | Medical condition in easily understood language |
Inguinal hernia liable to surgery without hospitalitation |
Hernia inguinal susceptible de corrección quirúrgica sin hospitalización |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
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 |
% of patients which can stand up theirselves 2 hours after spinal anesthesia (so we can confirm if cloroprocaina has the same qualities of prilocaina in ambulatory surgery) |
% de pacientes que pueden mantenerse en pie sin ayuda 2 horas después de la anestesia espinal (de este modo podríamos confirmar si la cloroprocaina tiene las mismas cualidades que la prilocaina en cirugía ambulatoria) |
|
E.2.2 | Secondary objectives of the trial |
% of patients which can stand up theirselves 2,5 hours after spinal anesthesia % of patients which can stand up theirselves 3 hours after spinal anesthesia Time to discharge Time to start feeling pain Number of complications Number of unexpected hospital admissions Number of hospital readmissions Satisfaction of the patient |
% de pacientes que pueden mantenerse en pie sin ayuda 2,5 horas después de la anestesia espinal % de pacientes que pueden mantenerse en pie sin ayuda 3 horas después de la anestesia espinal Tiempo hasta el alta Tiempo hasta el inicio de dolor Número de complicaciones Número de ingresos inesperados Número de reingresos Satisfacción del paciente con la técnica |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients over 18 years old Inguinal hernia Ambulatory surgery Signed consent |
Pacientes mayores de 18 años Hernia inguinal Cirugía ambulatoria Consentimiento firmado |
|
E.4 | Principal exclusion criteria |
Allergies to local anesthetics Contraindication to spinal anesthesia Contraindication to ambulatory surgery Pacient refusal |
Alergia a anestésicos locales Contraindicación para la anestesia espinal Contraindicación para la cirugía ambulatoria Rechazo del paciente |
|
E.5 End points |
E.5.1 | Primary end point(s) |
% of patients which can stand up theirselves 2 hours after spinal anesthesia |
% de pacientes que pueden mantenerse en pie sin ayuda 2 horas después de la anestesia espinal |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
2 hours after spinal anesthesia |
2 horas tras anestesia espinal |
|
E.5.2 | Secondary end point(s) |
% of patients which can stand up theirselves 2,5 hours after spinal anesthesia % of patients which can stand up theirselves 3 hours after spinal anesthesia Time to discharge Time to start feeling pain Number of complications Number of unexpected hospital admissions Number of hospital readmissions Satisfaction of the patient |
% de pacientes que pueden mantenerse en pie sin ayuda 2,5 horas después de la anestesia espinal % de pacientes que pueden mantenerse en pie sin ayuda 3 horas después de la anestesia espinal Tiempo hasta el alta Tiempo hasta el inicio de dolor Número de complicaciones Número de ingresos inesperados Número de reingresos Satisfacción del paciente con la técnica |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
2,5 hours after spinal surgery 3 hours after spinal surgery Before discharge
24 hours after surgery |
2,5 horas tras anestesia espinal 3 horas tras anestesia espinal Al alta de UCSI el día de la cirugía
24 horas tras cirugía |
|
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 | No |
E.6.4 | Safety | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
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
| 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 | 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
|
When we have arrived to patient number 100 or before if we can demostrate a significant difference between the two local anesthetics |
Cuando se lleguen a recoger todos los pacientes (100) o si se demuestra antes una diferencia significativa entre los dos anestésicos locales |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |