E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients undergoing knee replacement |
Pacientes sometidos a artoplastia de rodilla |
|
E.1.1.1 | Medical condition in easily understood language |
Patients who are going to be operated for the placement of knee replacement |
Pacientes que van a ser operados para la colocación de prótesis de rodilla |
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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.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
1) To compare the analgesic quality between two groups of patients who underwent bicompartmental unilateral total knee arthroplasty at Hospital Sant Joan de Reus, who will undergo a femoral block, associated or not with a tibial block at the popliteal level whit ropivacaine |
1) Comparar la calidad analgésica entre dos grupos de pacientes intervenidos de artroplastia total unilateral bicompartimental de rodilla en el Hospital Sant Joan de Reus, que serán sometidos a bloqueo femoral, asociado o no a bloqueo tibial a nivel poplíteo con ropivacaína. |
|
E.2.2 | Secondary objectives of the trial |
As secondary objectives:
2) Evaluate start of rehabilitation. 3) Quantify hospital stay. 4) Evaluate the postoperative clinical and functional complications. 5) Evaluate patient satisfaction. 6) Evaluate opiate use. |
Como objetivos secundarios:
2) Evaluar el inicio de la rehabilitación. 3) Cuantificar la estancia hospitalaria. 4) Evaluar las complicaciones clínicas y funcionales postoperatorias. 5) Evaluar la satisfacción del paciente. 6) Evaluar el uso de opiáceos. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The included patients will undergo unilateral primary total knee arthroplasty, aged between 50 and 80 years, ASA I-III, BMI <35 kg / m2, with no previous history of adverse effects and / or allergy to local anesthetics, NSAIDs , metamizole or tramadol, without psychiatric pathology, with correct cognitive capacity, as well as the understanding and written consent of their participation in this study. |
Los pacientes incluidos serán sometidos a artroplastia total primaria de rodilla unilateral, con edades comprendidas entre 50 y 80 años, ASA I-III, IMC <35 kg/m2, sin historia previa de efectos adversos y/o alergia frente a anestésicos locales, AINEs, metamizol o tramadol, sin patología psiquiátrica, con capacidad cognictiva correcta, así como el entendimiento y conformidad escrita de su participación en este estudio. |
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E.4 | Principal exclusion criteria |
Those patients with indication for primary total knee arthrosplasty with decompensated systemic diseases (hyperthyroidism, severe peripheral vascular disease, diabetics ...), prosthetic replacement surgeries, uncontrolled psychiatric disorders, denial or contraindication to intradural regional anesthesia and peripheral, with a previous history of adverse effects and / or allergy to local anesthetics, NSAIDs, metamizole or tramadol. |
Serán excluidos de este estudio aquellos pacientes con indicación de artrosplastia total primaria de rodilla con enfermedades sistémicas descompensadas (hipertiroidismo, vasculopatía periférica severa, diabéticos..), cirugías de recambio protésico, desórdenes psiquiátricos no controlados, negación o contraindicación a la anestesia regional intradural y periférica, con historia previa de efectos adversos y/o alergia frente a anestésicos locales, AINEs, metamizol o tramadol. |
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E.5 End points |
E.5.1 | Primary end point(s) |
-Analgesic evaluation according to the EN scale (numerical scale: 0-10) |
-Valoración analgésica según escala EN ( escala numérica: 0-10) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
-Analgesic evaluation according to the EN scale (numerical scale: 0-10) in the immediate postoperative period, upon discharge from the URPA (postanesthetic recovery unit), 6-12-24-36 and at 48 hours, at rest and in motion, considering mild pain less than or equal to 3, moderate from 4 to 6 and severe greater than 7. |
-Valoración analgésica según escala EN ( escala numérica: 0-10) en el postoperatorio inmediato, al alta de la URPA (unidad de recuperación postanestésica), 6-12-24-36 y a las 48 horas, en reposo y en movimiento, considerando dolor leve menor o igual a 3, moderado de 4 a 6 y severo mayor de 7. |
|
E.5.2 | Secondary end point(s) |
- Demographic: age, sex and BMI (weight and height). - ASA (I-III). - Assessment of functionality in basic activities: preoperative Barthel index. - Surgical time in minutes. - Ischemia time in minutes. - Type of knee prosthesis. - Assessment of motor and sensitive block in URPA. Reversion time. - Consumption of postoperative analgesia in the first 48h. - Time elapsed until the first rescue analgesic. - Postoperative pharmacological and technical complications and side effects. - Rehabilitation start at 24h. - Assessment of risk of falling: Tinetti scale at 24 hours after surgery and before discharge. - Days of hospital stay. - Overall patient satisfaction at discharge: very satisfied, acceptable or dissatisfied. - Would you repeat the technique performed? YES/NO |
- Demográficas: edad , sexo e IMC (peso y talla). - ASA (I-III). - Valoración de la funcionalidad en actividades básicas: Índice de Barthel preoperatorio. - Tiempo quirúrgico en minutos. - Tiempo isquemia en minutos. - Tipo de prótesis de rodilla. - Valoración de bloqueo motor y sensitivo en URPA. Hora reversión. - Consumo de analgesia postoperatoria en las primeras 48h. - Tiempo transcurrido hasta el primer analgésico de rescate. - Complicaciones y efectos secundarios farmacológicos y técnicos postoperatorios. - Inicio rehabilitación a las 24h. - Valoración riesgo de caída: Escala Tinetti a las 24h postquirúrgicas y previo al alta. - Días de estancia hospitalaria. - Satisfacción global del paciente al alta: muy satisfecho, aceptable o insatisfecho. - ¿Volvería a repetir la técnica realizada?. SI / NO. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Patient control during the first 48 postoperative hours |
Control de paciente durante las primeras 48 horas postoperatorias |
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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 | 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) | 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 | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Dos grupos asignados de forma aleatoria |
Two random groups |
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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 |
Bloqueo femoral vs bloqueo femoral + bloqueo tibial con ropivacaína |
Femoral block vs femoral block + tibial block whit ropivacaine |
|
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
|
The study will end when the data for the total 60 patients (30 per group) have been collected |
El estudio acabará cuando se acaben de recoger los datos de los 60 pacientes totales (30 por grupo) |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |