E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
AMBULATORY LAPAROSCOPIC COLECISTECTOMY |
COLECISTECTOMIA LAPAROSCOPICA AMBULATORIA |
|
E.1.1.1 | Medical condition in easily understood language |
AMBULATORY LAPAROSCOPIC COLECISTECTOMY |
COLECISTECTOMIA LAPAROSCOPICA AMBULATORIA |
|
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 |
Compare the efficacy of the treatment according to the NSAID administration schedule, before and after the surgical aggression. For this, it is desired to know if there is a significant difference in the consumption of Fentanyl (in ug) between the two groups to be evaluated in the study. |
Comparar la eficacia del tratamiento según pauta de administración del AINE, antes y después de la agresión quirúrgica. Para ello, se desea conocer si existe una diferencia significativa en el consumo de Fentanilo (en ug) entre los dos grupos a evaluar en el estudio. |
|
E.2.2 | Secondary objectives of the trial |
In addition to the main objective of the study, we want to assess whether the difference in treatment between the two groups of patients has consequences on other variables of interest such as T1, recovery quality (QoR-15), ENV, NVPO, TURPA , TSAM. Adverse effects will be recorded with ibuprofen ev administration. |
Además del objetivo principal del estudio, se quiere evaluar si la diferencia en el tratamiento entre los dos grupos de pacientes tiene consecuencias sobre otras variables de interés como el T1, la calidad de la recuperación (QoR-15), el ENV, NVPO, TURPA, TSAM. Se registrarán los efectos adversos con la administración ev de Ibuprofeno. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
That is over 18 years, of both sexes, ASA I-III. Accept participation in the study (CI that will be signed by the patient or relative depending on the degree of autonomy of the patient). All patients who will undergo laparoscopic cholecystectomy in the CMA unit will be included for 2 years from the start date of the study in the center. |
Que sea mayor de 18 años, de ambos sexos, ASA I-III. Aceptar la participación en el estudio (CI que será firmado por el paciente o familiar dependiendo del grado de autonomía del paciente). Se incluirán todos los pacientes que van a ser intervenidos de colecistectomía laparoscópica en la unidad de CMA durante 2 años desde la fecha de inicio del estudio en el centro.
|
|
E.4 | Principal exclusion criteria |
-History of allergy or hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs). -Chronic use of opioids or NSAIDs. -Severe liver or kidney insufficiency. -History of hemorrhagic diathesis, history of gatrointestinal bleeding, peptic ulcer or inflammatory bowel disease. -Pregnancy or breastfeeding. -Patients undergoing coronary revascularization surgery, patients with severe heart failure (HF) or ischemic cardiomyopathy. -History or hypersensitivity history to Pyrazolones or Paracetamol. -Open cholecystectomy (laparotomy). |
En tratamiento con otro fármaco experimental. Pacientes con historia de alergia o hipersensibilidad a AINES, uso crónico de opioides o AINES, insuficiencia hepática o renal severa, historia de diátesis hemorrágica, antecedentes de sangrado gastrointestinal, úlcera péptica o enfermedad inflamatoria intestinal, embarazo o lactancia, pacientes sometidos a cirugía de revascularización coronaria, pacientes con insuficiencia cardiaca (IC) severa o miocardiopatía isquémica. Pacientes con historia de alergia o hipersensibilidad a Pirazolonas o Paracetamol. Paciente que requiera ingreso hospitalario. Colecistectomía abierta (laparotomía).
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Morphic consumption in the immediate postoperative period |
• Consumo total de Fentanilo (ug) en el postoperatorio inmediato (desde fin de la cirugía hasta el alta de CMA).
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Total consumption of Fentanyl (ug) in the immediate postoperative period (from the end of surgery until discharge from CMA). |
Consumo total de fentanilo (ug) en el postoperatorio inmediato (desde el final de la cirugía hasta el alta del CMA). |
|
E.5.2 | Secondary end point(s) |
Assess whether the difference in treatment between the two groups of patients has consequences on other variables of interest such as T1, recovery quality (QoR-15), ENV, NVPO, TURPA , TSAM. Adverse effects will be recorded with ibuprofen ev administration. |
evaluar si la diferencia en el tratamiento entre los dos grupos de pacientes tiene consecuencias sobre otras variables de interés como el T1, la calidad de la recuperación (QoR-15), el ENV, NVPO, TURPA, TSAM. Se registrarán los efectos adversos con la administración ev de Ibuprofeno. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
T1: Time, in minutes, from the end of the surgery until the first morphic rescue. • Quality of recovery through questionnaire QoR-15 (scale 0-10), 15 items) performed before surgery (Q0), at 24h (Q1) at 72h (Q2) and at week (Q3) • ENV (scale 0-10) at rest at 0h, 1h, 2h, 4h and at rest / movement at 6h, at discharge, at 24h, 72h and one week after surgery. • NVPO: Yes / No. Need for rescue medication: Yes / No • TURPA and TSAM in minutes. • Adverse reaction with the administration of Ibuprofen ev. • Surgery time. • Anesthesia time. |
• T1: Tiempo, en minutos, desde fin de la cirugía hasta el primer rescate mórfico. • Calidad de recuperación mediante cuestionario QoR-15 (escala 0-10), 15 items) realizado antes de la cirugía (Q0), a las 24h (Q1) a las 72h (Q2) y a la semana (Q3) • ENV (escala 0-10) en reposo a las 0h,1h, 2h, 4h y en reposo/movimiento a las 6h, al alta, a las 24h, 72h y a la semana de la cirugía. • NVPO: Si/No. Necesidad de medicación de rescate: Si/No • TURPA y TSAM en minutos. • Reacción Adversa con la administración ev de Ibuprofeno. • Tiempo de cirugía. • Tiempo de anestesia.
|
|
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 | No |
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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
800 MG Ibuprofen before the surgical incision; 800mg ev of Ibuprofen at the end of surgery |
|
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
|
|
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 | |