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Departamento De Cirugía DEPARTAMENTO DE CIRUGÍA ENSAYO CLÍNICO, RANDOMIZADO, PARALELO, FASE IV, DE EFICACIA DE LEVOBUPIVACAÍNA MÁS FENTANILO 1µg/ml CONTROLADO CON BUPIVACAÍNA MÁS FENTANILO 1µg/ml Y ROPIVACAÍNA MÁS FENTANILO 1µg/ml EN LA ANALGESIA EPIDURAL DEL PARTO Mª CARMEN ATIENZAR GÓMEZ UNIVERSITAT DE VALENCIA Servei de Publicacions 2005 Aquesta Tesi Doctoral va ser presentada a Valencia el día 12 de Setembre de 2005 davant un tribunal format per: - D. Miguel Tortajada Martínez - D. Julio Cortijo Gimeno - D. Raimundo Carlos García - D. Clemente Muriel Villoria - D. Esteban Morcillo Sánchez Va ser dirigida per: D. José María Palanca Sanfrancisco Dª. Rosa Mª Borras Ramírez ©Copyright: Servei de Publicacions Mª Carmen Atienzar Gómez Depòsit legal: I.S.B.N.:84-370-6365-5 Edita: Universitat de València Servei de Publicacions C/ Artes Gráficas, 13 bajo 46010 València Spain Telèfon: 963864115 Ensayo clínico randomizado, paralelo, fase IV, de eficacia de levobupivacaína más fentanilo 1μg/ml controlado con bupivacaína más fentanilo 1μg/ml y ropivacaína más fentanilo 1μg/ml en la analgesia epidural del parto. UNIVERSITAT DE VALÈNCIA DEPARTAMENT DE CIRURGIA FACULTAT DE MEDICINA I ODONTOLOGIA UNIVERSITAT AUTÒNOMA DE BARCELONA INSTITUT UNIVERSITARI DEXEUS TESIS DOCTORAL Presentada por: Mª Carmen Atiénzar Gómez Directores: José Mª Palanca Sanfrancisco Rosa Mª Borràs Ramírez Valencia, Abril 2005. A mis padres, por darme la oportunidad de ser doctora. A mi marido, por darme la oportunidad de ser feliz. Agradecimientos. A todos los que me han ayudado de alguna manera a que esta tesis se hiciera realidad. A Salvador Quintana, que me introdujo, hace ya cuatro años, en el apasionante mundo de la estadística, dedicándome su tiempo libre y toda su paciencia. A Ferran Torres, que me guió en mi primer estudio, desde el diseño a la estadística, y con quién siempre he podido contar desde entonces. Al profesor Palanca, que desde la distancia ha estado siempre tan cercano, ayudándome, y estimulándome siempre para que siguiera trabajando. A mis compañeros del I.U. Dexeus, por todo lo que me han enseñado, por haber sido mis maestros. A Rosa Borrás, por creer en este proyecto y darme su apoyo. A Carbonell, por haberme ayudado a superar los momentos difíciles. A Yolanda Filella, por estar siempre dispuesta a escuchar. A mis compañeras de residencia, por hacer que entre todas todo fuera más fácil. A Yoli, Tete y Dani, por darme ánimos, sobre todo cuando parecía que esto nunca se acabaría. A mis amigas, a quienes no he podido ver tanto como me hubiera gustado. INDICE I. INTRODUCCIÓN............................................................1 I.1. EL PARTO A TRAVÉS DE LA HISTORIA................................................................3 I.2. LAS VÍAS DEL DOLOR EN EL PARTO Y SU IMPLICACIÓN EN CADA ESTADIO...10 I.2.1. Definición de dolor: el dolor del parto.................................................10 I.2.2. Dolor en el trabajo del parto..............................................................12 I.2.2.1. Primera etapa del trabajo del parto..................................12 I.2.2.2. Segunda etapa del trabajo del parto.................................15 I.2.2.3. Tercera y cuarta epata del trabajo del parto.....................16 I.2.3.Vías de transmisión nocioceptivas......................................................16 I.2.3.1. Bases anatómicas del dolor : neuroanatomía....................16 I.2.3.2. Neuroquímica funcional del dolor.....................................31 I.2.4. Factores que influyen sobre el dolor del parto....................................50 I.2.4.1. Cambios neurohormonales...............................................52 I.2.4.2. Determinantes obstétricos y físicos..................................53 I.2.4.3. Consideraciones psicológicas y culturales.......................54 I.2.5. Efectos del dolor y de la analgesia epidural........................................55 I.2.5.1. Reflejos espinales.............................................................55 I.2.5.2. Reflejos suprasegmentarios..............................................56 I.2.5.3. Respuesta cortical............................................................57 I.2.5.4. Efectos de la analgesia epidural........................................57 I.3. POSIBILIDADES EN EL MANEJO DEL DOLOR DEL TRABAJO DE PARTO.........58 I.3.1. Alivio no farmacológico del dolor........................................................58 I.3.1.1. Preparación para el parto.................................................58 I.3.1.2. Estimulación sensitiva.....................................................60 I.3.2. Analgesia sistémica...........................................................................63 I.3.2.1. Transferencia placentaria de fármacos.............................63 I.3.2.2. Opiodes agonistas............................................................64 I.3.2.3. Opiodes agonistas-antagonistas.......................................68 I.3.2.4. Opiodes antagonistas.......................................................69 I.3.2.5. Tranquilizantes................................................................70 I.3.2.6. Agentes intravenosos de inducción anestésica..................73 I.3.3. Analgesia por inhalación...................................................................74 I.3.4. Bloqueo de nervios periféricos...........................................................75 I.3.4.1. Bloqueo paracervical........................................................75 I.3.4.2. Bloqueo de pudendos.......................................................77 I.3.5. Analgesia regional.............................................................................78 I.3.5.1. Analgesia epidural lumbar...............................................78 I.3.5.2. Bloqueo intradural...........................................................85 I.3.5.3. Técnicas combinadas (Epidural/Intradural)......................88 I.3.5.4. Complicaciones asociadas al bloqueo espinal....................90 I.4. FARMACOLOGÍA ..............................................................................................97 I.4.1. Anestésicos locales...........................................................................97 I.4.1.1. Estructura química y propiedades generales....................97 I.4.1.2.Mecanismo de acción........................................................98 I.4.1.3.Características de los anestésicos locales.........................101 I.4.2. Levobupivacaína..............................................................................102 I.4.2.1. Estructura.....................................................................102 I.4.2.2. Farmacodinámica...........................................................103 I.4.2.3.Farmacocinética..............................................................105 I.4.2.4. Uso terapéutico..............................................................106 I.4.2.5. Tolerabilidad..................................................................108 I.4.2.6. Posología y administración.............................................110 I.4.3. Ropivacaína.....................................................................................112 I.4.3.1. Estructura.....................................................................112 I.4.3.2. Farmacodinámica...........................................................113 I.4.3.3.Farmacocinética..............................................................114 I.4.3.4. Uso terapéutico..............................................................115 I.4.3.5. Tolerabilidad..................................................................118 I.4.3.6. Posología y administración.............................................119 I.4.4. Bupivacaína....................................................................................121 I.4.4.1. Estructura.....................................................................121 I.4.4.2. Farmacodinámica...........................................................122 I.4.4.3.Farmacocinética..............................................................124 I.4.4.4. Uso terapéutico..............................................................126 I.4.4.5. Tolerabilidad..................................................................127 I.4.4.6. Posología y administración.............................................127 I.4.5. Opiodes...........................................................................................130 I.4.5.1. Mecanismos de acción de los opiodes.............................130 I.4.5.2. Clasificación...................................................................132 I.4.6. Fentanilo.........................................................................................134 I.4.6.1. Estructura.....................................................................134 I.4.6.2. Farmacocinética y farmacodinámica...............................134 I.4.6.3. Efectos farmacológicos...................................................136 I.4.6.4. Utilización clínica...........................................................139 II. HIPÓTESIS DE TRABAJO...........................................143 III. OBJETIVOS...............................................................145 III.1. OBJETIVO FUNDAMENTAL...........................................................................147 III.2. OBJETIVOS SECUNDARIOS..........................................................................147 IV. MATERIAL Y MÉTODO...............................................149 IV.1. INFORMACION GENERAL..............................................................................151
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