E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prostate cancer |
Cáncer de próstata |
|
E.1.1.1 | Medical condition in easily understood language |
Prostate cancer |
Cáncer de próstata |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060862 |
E.1.2 | Term | Prostate cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 the effectiveness of postoperative analgesia through local infiltration of surgical wounds with respect to the transversus abdominis plane block. |
Evaluación de la efectividad de la analgesia postoperatoria tras la infiltración local de las heridas quirúrgicas respecto el bloqueo transversus abdominis plane. |
|
E.2.2 | Secondary objectives of the trial |
- Length of in-hospital stay - Evaluation time to intake - Evaluation time to the first flatus - Evaluation time to sitting position - Evaluation time to perambulation |
- Evaluación de la estancia hospitalaria - Evaluación del inicio de la tolerancia oral - Evaluación del inicio del peristaltismo - Evaluación del inicio de la sedestación - Evaluación del inicio de la deambulación |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Informed consent form signed and dated, and willingness and ability to accomplish the protocol requirements 2. Histologically confirmed prostate adenocarcinoma 3. Candidate for radical surgery by laparoscopic approach 4. Age> 18 years 5. Feasibility of performing regular monitoring |
1. Consentimiento informado firmado y fechado, y disposición y capacidad para cumplir con los requisitos del procolo 2. Adenocarcinoma de próstata confirmado histológicamente 3. Paciente candidato a cirugía radical via laparoscópica 4. Edad >18 años 5. Viabilidad de realización de un seguimiento regular |
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E.4 | Principal exclusion criteria |
1. Patients who do not agree to participate in the study 2. History of allergy to local anesthetics and opioid 3. Patients in chronic opioid treatment 4. Age <18 years |
1. Pacientes que no acepten participar en el estudio 2. Historia de alergia a anestésicos locales y opiáceos 3. Pacientes en tratamiento crónico de opioides 4. Edad<18 años |
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E.5 End points |
E.5.1 | Primary end point(s) |
Assessment of acute postoperative pain |
Valoración del dolor agudo postoperatorio |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Assessment of acute postoperative pain at 1 hour, at 2 hours, at 3 hours, at 4 hours, at 6 hours, at 12 hours, at 18 hours, at 24 hours, at 36 hours and at 48 hours after the end of the surgery |
Valoración del dolor agudo postoperatorio a la 1 hora, 2 hora, 3 hora, 4 hora, 6 hora, 12 hora, 18 hora, 24 hora, 36 hora y 48 hora tras haber finalizado la cirugía |
|
E.5.2 | Secondary end point(s) |
- Evaluation of the first flatus - Assessment of the start intake - Assessment of the start sitting - Assessment of the start perambulation - Record the numer of days hospitalized |
- Valoración del inicio del peristaltismo - Valoración del inicio de la tolerancia oral - Valoración del inicio de la sedestación - Valoración del inicio de la deambulación - Registro de la estancia hospitalaria |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Evaluation of the first flatus during the stay in the post-anaesthetic care unit and in the conventional hospitalization ward. - Assessment of the start intake during the stay in the post-anaesthetic care unit and in the conventional hospitalization ward. - Assessment of the start sitting position during the stay in conventional hospitalization ward. - Assessment of the start perambulation during the stay in conventional hospitalization ward. - Record the number of days hospitalized after hospital discharge |
- Valoración del inicio del peristaltismo durante su estancia en la unidad de reanimación postanestésica y en la planta - Valoración del inicio de la tolerancia oral durante su estancia en la unidad de reanimación postanestésica y en la planta - Valoración del inicio de la sedestación durante su estancia en la planta - Valoración del inicio de la deambulación durante su estancia en la planta - Registro de la estancia hospitalaria al ser dado de alta del hospital |
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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 | 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) | 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 | Yes |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Queremos comparar la eficacia analgésica de dos técnicas diferentes con el mismo mkedicamento |
We want to compare the analgesic efficacy of two different techniques with the same medication |
|
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
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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 | |