E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Analgesia postoperatoria en gestantes sometidas a cesárea bajo anestesia intradural |
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E.1.1.1 | Medical condition in easily understood language |
Tratamiento del dolor tras cesárea |
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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 | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020573 |
E.1.2 | Term | Hyperalgesia |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10024760 |
E.1.2 | Term | Local anesthetic |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066714 |
E.1.2 | Term | Acute pain |
E.1.2 | System Organ Class | 10018065 - General disorders and administration site conditions |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052673 |
E.1.2 | Term | Wound irrigation |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049475 |
E.1.2 | Term | Chronic pain |
E.1.2 | System Organ Class | 10018065 - General disorders and administration site conditions |
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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 |
Evaluar el área de hiperalgesia secundaria periincisional en pacientes sometidas a cesárea bajo anestesia intradural tras la administración de levobupivacaina en la herida quirúrgica mediante catéter incisional en un contexto de analgesia multimodal |
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E.2.2 | Secondary objectives of the trial |
medir la calidad de la analgesia postoperatoria (alivio del dolor con EVA en reposo y movimiento), descenso de los requerimientos de morfina, la respuesta de estrés, incidencia de dolor crónico y la incidencia de dolor crónico y la incidencia de complicaciones o efectos adversos relacionados con la técnica y el índice de satisfacción experimentada por las pacientes |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Farmacocinética de la levobupivacaína en plasma y leche materna |
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E.3 | Principal inclusion criteria |
Gestantes a término sometidas a cesárea programada bajo anestesia intradural. Pacientes debidamente informadas y que han firmado el consentimiento informado durante la consulta preanestésica, o en su caso ser recabado tras la debida meditación, expresando su conformidad para la inclusión en el estudio. Edad comprendida entre 18 - 45 años. ASA I y II. Capacidad intelectual suficiente para entender la técnica así como el equipo empleado. |
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E.4 | Principal exclusion criteria |
No cumplir alguno de los criterios anteriormente expuestos Presencia de trastorno médico mayor, cardiovascular, pulmonar, metabólico, renal o hepático. Preeclampsia y/o Síndrome HELLP Coagulopatía Sangrado profuso superior a 1000 ml o aquel que provoque una inestabilidad hemodinámica que requiera fluidoterapia y/o transfusión agresiva. Alergia a cualquier fármaco incluido en el protocolo. Patología psiquiátrica o neurológica. Infección preexistente. Tratamiento previo con mórficos, antidepresivos o padecer dolor crónico. Historia de abuso de alcohol o drogas o consumo conocido de fármacos que interfieran con el metabolismo de la LB. |
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E.5 End points |
E.5.1 | Primary end point(s) |
disminuir el área de hiperalgesia secundaria en al menos 18 cm2 y el dolor crónico en el postoperatorio de una cesárea |
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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) |
Puntuación de dolor (mediante la escala visual analógica en reposo y en movimiento). Evaluación de los requerimientos de morfina y paracetamol Incidencia de dolor crónico Variables farmacocinéticas de la levobupivacaína en plasma y leche materna Marcadores de estrés Incidencia de complicaciones y/o efectos adversos relacionados con la técnica Índice de satisfacción experimentado por las pacientes. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Puntuación de dolor: 72 horas Evaluación de los requerimientos de morfina y paracetamol: 48horas Incidencia de dolor crónico: 6 meses Variables farmacocinéticas de la levobupivacaína en plasma y leche materna: 60 horas Marcadores de estrés:60h Incidencia de complicaciones y/o efectos adversos relacionados con la técnica: 72 horas Índice de satisfacción experimentado por las pacientes : 72 horas |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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) | 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 | 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 | Yes |
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
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La intervención terapéutica dura 48 horas pero el control se extiende alrededor de 6 meses después para valorar el dolor crónico |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |