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Resúmenes Epistemonikos
Medwave 2017 Nov-Dic;17(9):e7115 doi: 10.5867/medwave.2017.09.7115
¿Es efectiva la pregabalina perioperatoria para reducir el dolor postoperatorio en cirugías mayores?
Is perioperative pregabalin effective for reducing postoperative pain in major surgery?
José Canihuante, Ian Molina, Fernando Altermatt
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Resumen

INTRODUCCIÓN
La pregabalina es un análogo estructural del ácido γ-aminobutírico (GABA), por lo que se cree que pudiese tener un rol en el manejo del dolor agudo. Ha sido utilizada en el contexto perioperatorio, pero existe controversia en relación a su real utilidad clínica.

MÉTODOS
Para responder esta pregunta utilizamos Epistemonikos, la mayor base de datos de revisiones sistemáticas en salud, la cual es mantenida mediante búsquedas en múltiples fuentes de información, incluyendo MEDLINE, EMBASE, Cochrane, entre otras. Extrajimos los datos desde las revisiones identificadas, reanalizamos los datos de los estudios primarios, realizamos un metanálisis y preparamos tablas de resumen de los resultados utilizando el método GRADE.

RESULTADOS Y CONCLUSIONES
Identificamos 21 revisiones sistemáticas que en conjunto incluyen 77 ensayos aleatorizados. Concluimos que el uso de pregabalina perioperatoria en cirugías mayores probablemente no produce una disminución clínicamente importante del dolor postoperatorio agudo. Si bien podría disminuir las náuseas y vómitos postoperatorios y el requerimiento de opioides, produce también un aumento en la sedación.


 
Problema

El manejo del dolor postoperatorio es un aspecto importante dentro de la práctica de la anestesiología. Entre las drogas más utilizadas para manejar el dolor agudo se encuentran los opioides, los cuales pese a ser muy efectivos, poseen efectos adversos como náuseas, vómitos, sedación y depresión respiratoria. Una de las estrategias para reducir estos efectos no deseados es utilizar analgésicos adyuvantes que actúen a través de distintas vías involucradas en la respuesta al dolor.

La pregabalina es un análogo estructural del ácido γ-aminobutírico (GABA) que se une a la subunidad α2δ de los canales de calcio voltaje-dependientes en el sistema nervioso central disminuyendo la liberación de diversos neurotransmisores. Aunque usualmente es utilizado como antiepiléptico y para el manejo del dolor crónico, se ha planteado también su rol para el manejo del dolor postoperatorio agudo. Sin embargo, existe controversia sobre si realmente corresponde a una alternativa terapéutica efectiva en este contexto. 

Metodos

Para responder esta pregunta utilizamos Epistemonikos, la mayor base de datos de revisiones sistemáticas en salud, la cual es mantenida mediante búsquedas en múltiples fuentes de información, incluyendo MEDLINE, EMBASE, Cochrane, entre otras. Extrajimos los datos desde las revisiones identificadas y reanalizamos los  datos de los estudios primarios. Con esta información, generamos un resumen estructurado denominado FRISBEE (Friendly Summaries of Body of Evidence using Epistemonikos), siguiendo un formato preestablecido, que incluye mensajes clave, un resumen del conjunto de evidencia (presentado como matriz de evidencia en Epistemonikos), metanálisis del total de los estudios cuando sea posible, tablas de resumen de resultados con el método GRADE, y tabla de otras consideraciones para la toma de decisión.

Mensajes clave

  • El uso de pregabalina perioperatoria en cirugías mayores probablemente no produce una disminución clínicamente importante del dolor postoperatorio agudo. 
  • El uso de pregabalina perioperatoria aumenta la sedación postoperatoria.
  • El uso de pregabalina perioperatoria en cirugías mayores podría disminuir el consumo postoperatorio de opioides y la incidencia de náuseas y vómitos, pero la certeza de esta evidencia es baja.
Acerca del conjunto de evidencia para esta pregunta

Cuál es la evidencia
Véase matriz de evidencia en Epistemónikos más abajo.

Encontramos 21 revisiones sistemáticas [1],[2],[3],[4],
[5],[6],[7],[8],[9],[10],[11],[12],[13],[14],[15],
[16],[17],[18],[19],[20],[21] que incluyen 77 ensayos

aleatorizados [22],[23],[24],[25],[26],[27],[28],[29],
[30],[31],[32],[33],[34],[35],[36],[37],[38],[39],
[40],[41],[42],[43],[44],[45],[46],[47],[48],[49],
[50],[51],[52],[53],[54],[55],[56],[57],[58],[59],
[60],[61],[62],[63],[64],[65],[66],[67],[68],[69],
[70],[71],[72],[73],[74],[75],[76],[77],[78],[79],
[80],[81],[82],[83],[84],[85],[86],[87],[88],[89],
[90],[91],[92],[93],[94],[95],[96],[97],[98].

Qué tipo de pacientes incluyeron los estudios*

En 16 ensayos se incluyeron pacientes sometidos a cirugía abdominal [22],[23],[24],[26],[29],[30],[31],[35],[37],
[42],[69],[78],[82],[86],[88],[89], en 21 ensayos pacientes sometidos a cirugía pélvica o ginecológica [28],[39],[43],
[45],[49],[50],[52],[56],[58],[59],[60],[65],[68],[73],[76],
[80],[81],[82],[84],[90],[97], en 30 ensayos pacientes sometidos a cirugía traumatológica [25],[32],[33],[34],
[36],[38],[40],[41],[44],[48],[51],[53],[54],[55],[57],[62],
[63],[67],[70],[71],[72],[74],[75],[77],[82],[83],[91],[93],
[95],[96], en cinco ensayos pacientes sometidos a cirugía torácica [46],[61],[79],[92],[98];y en siete ensayos se incluyeron pacientes sometidos a otras cirugías [27],[47],
[64],[66],[85],[87],[94]
  

Qué tipo de intervenciones incluyeron los estudios*

En todos los ensayos se administró pregabalina vía oral.

En 49 ensayos se administró pregabalina durante el preoperatorio [23],[24],[25],[26],[27],[28],[29],[31],[35],
[38],[39],[42],[43],[44],[46],[48],[49],[50],[51],[52],[54],
[55],[56],[60],[64],[65],[67],[68],[69],[70],[71],[72],[73],
[75],[76],[80],[82],[84],[85],[86],[87],[88],[89],[91],[92],
[93],[94],[97],[98], en 26 ensayos en el preoperatorio y luego en el postoperatorio [22],[30],[32],[33],[34],[36],
[37],[40],[41],[45],[47],[53],[57],[58],[59],[61],[62],[63],
[66],[77],[78],[79],[83],[90],[95],[96] y en el resto este dato no fue reportado.

En 46 ensayos se administró una dosis única de
pregabalina [23],[24],[25],[26],[27],[28],[29],[31],
[35],[38],[39],[42],[43],[46],[48],[50],[51],[54],[55],
[56],[60],[64],[65],[67],[68],[69],[70],[71],[72],[73],
[75],[76],[80],[82],[85],[87],[88],[89],[91],[92],[93],
[94],[95],[96],[97],[98], en 27 ensayos se administraron múltiples dosis de pregabalina [22],[30],[32],[33],[34],
[36],[37],[40],[41],[44],[45],[47],[49],[52],[53],[57],
[58],[59],[61],[62],[63],[66],[77],[78],[79],[83],[90] y en el resto  este dato no fue reportado.

Las dosis de pregabalina utilizadas variaron entre 50 mg y 600 mg. 

En un ensayo se coadministró dexametasona [51], en dos ensayos remifentanil en infusión [58],[69], en dos ensayos antiinflamatorios no esteroidales [60],[70], en un ensayo paracetamol [73], en un ensayo paracetamol y diclofenaco [55], y en el resto de los ensayos no hubo coadministración de fármacos junto a pregabalina.

En cuanto a la analgesia postoperatoria, en dos ensayos se utilizó paracetamol junto con AINEs [36],[95], en 12 ensayos se utilizó paracetamol junto con opioides [45],[46],
[52],[55],[60],[61],[72],[73],[78],[79],[86],[93], en nueve ensayos se utilizó sólo AINEs [22],[24],[28],[37],[39],[42],
[51],[80],[87], en 13 ensayos se utilizó AINEs y opioides [27],[30],[35],[49],[50],[53],[54],[57],[63],[64],
[67],[69],[70], en 30 ensayos se utilizó sólo opioides [23],
[25],[26],[29],[31],[33],[34],[38],[40],[43],[44],[47],[56],
[58],[62],[66],[68],[71],[75],[77],[82],[83],[84],[88],[89],
[90],[92],[94],[97],[98], en tres ensayos se utilizó paracetamol, AINEs y opioides [76],[91],[96] y en tres ensayos no reportaron este dato [74],[81],[85].

En 68 ensayos se comparó contra placebo [22],[23],
[25],[26],[27],[29],[30],[31],[32],[33],[34],[35],[36],
[37],[38],[39],[40],[41],[42],[43],[44],[45],[46],[48],
[49],[50],[51],[52],[53],[54],[55],[57],[58],[61],[62],
[63],[64],[65],[66],[67],[68],[71],[72],[73],[74],[75],
[76],[77],[78],[79],[80],[81],[82],[83],[84],[85],[86],
[88],[89],[90],[91],[92],[93],[94],[95],[96],[97],[98],  en 20 ensayos se comparó contra otra droga [24],[30],[36],
[38],[47],[50],[56],[58],[59],[60],[62],[67],[69],[70],[71],
[75],[77],[80],[82],[87], en tres ensayos se comparó contra pregabalina junto a otra droga [72],[73],[83] y en el resto no fue reportado.

Qué tipo de desenlaces midieron

Los principales desenlaces analizados por las revisiones sistemáticas fueron: dolor postoperatorio, sedación, consumo de opioides, estadía en unidad de recuperación, ansiedad preoperatoria, efectos adversos, náuseas y vómitos postoperatorios, y morbilidad. 

El seguimiento promedio de los ensayos fue de 24 horas, con un rango que fluctuó entre las 2 hasta las 72 horas postoperatorias.

* La información sobre los estudios primarios es extraída desde las revisiones sistemáticas identificadas, no directamente desde los estudios, a menos que se especifique lo contrario.

Cuál es la evidencia

Véase matriz de evidencia en Epistemónikos más abajo.
Resumen de los resultados

La información sobre los efectos de la pregabalina perioperatoria está basada en 53 ensayos aleatorizados, que incluyen 3543 pacientes en total [23],[26],[29],[30],[31],[32],[33],[34],[35],[36],[37],[38],[40],[41],[44],[45],[49],[50],[52],[53],[54],[56],[57],[58],[59],[60],[61],[63],[64],[65],[66],[69],[70],[72],[73],[74],[75],[76],[77],[78],[79],[81],[84],[85],[86],[90],[91],[92],[93],[94],[95],[96],[97]. El resto de los ensayos no reportó los desenlaces de interés o lo hizo de una forma en la que no fue posible incorporarlos en un metanálisis

Cuarenta y seis ensayos midieron el desenlace dolor postoperatorio a las 24 horas (3037 pacientes) [23],[26],[30],[31],[32],[33],[34],[35],[36],[37],[38],[40],[41],[44],[45],[49],[50],[53],[54],[56],[57],[58],[59],[60],[61],[63],[64],[66],[69],[70],[72],[73],[75],[76],[77],[78],[81],[85],[86],[90],[91],[92],[93],[94],[96],[97], 27 ensayos midieron el desenlace consumo de opioides (1712 pacientes) [23],[31],[35],[37],[44],[45],[49],[50],[52],[53],[56],[58],[59],[60],[63],[66],[72],[73],[77],[78],[79],[84],[91],[92],[96],[97], 31 ensayos midieron el desenlace náuseas y vómitos (2461 pacientes) [23],[29],[31],[32],[33],[35],[37],[38],[50],[53],[56],[57],[59],[60],[64],[65],[69],[72],[73],[74],[77],[78],[79],[84],[86],[90],[91],[93],[95],[96],[97] y 18 ensayos midieron el desenlace sedación (1587 pacientes) [23],[31],[33],[36],[37],[38],[53],[56],[61],[63],[64],[65],[72],[73],[90],[91],[95],[96].

El resumen de los resultados es el siguiente:

  • El uso de pregabalina perioperatoria en cirugías mayores probablemente no produce una disminución clínicamente importante del dolor postoperatorio agudo. La certeza de esta evidencia es moderada
  • El uso de pregabalina perioperatoria en cirugías mayores podría disminuir el consumo postoperatorio de opioides. La certeza de esta evidencia es baja.
  • El uso de pregabalina perioperatoria en cirugías mayores podría disminuir la incidencia de náuseas y vómitos postoperatorios. La certeza de esta evidencia es baja.
  • El uso de pregabalina perioperatoria en cirugías mayores produce un aumento de la sedación postoperatoria. La certeza de esta evidencia es alta.

Otras consideraciones para la toma de decisión

A quién se aplica y a quién no se aplica esta evidencia

  • Los resultados de este resumen son aplicables a pacientes adultos sometidos a cirugías abdominales, pélvicas o ginecológicas, traumatológicas, torácicas, y otras cirugías mayores; y que reciben anestesia general o neuroaxial.
  • No es posible determinar si existe un efecto diferente en alguno de los subgrupos evaluados en este resumen. 
Sobre los desenlaces incluidos en este resumen
  • Entre los desenlaces evaluados se encuentran aquellos considerados críticos para la toma de decisión por los autores de este resumen. En general coinciden con los utilizados por las revisiones identificadas.
Balance riesgo/beneficio y certeza de la evidencia
  • La pregabalina perioperatoria probablemente produce una disminución del dolor postoperatorio agudo de 0,45 puntos (EVA 0-10), lo cual se encuentra por debajo de la diferencia mínimamente importante establecida en la literatura para el contexto de dolor perioperatorio [99].
  • La pregabalina perioperatoria podría disminuir el consumo de opioides y la incidencia de náuseas y vómitos postoperatorios, sin embargo, la certeza de la evidencia es baja.
  • Además, la pregabalina perioperatoria probablemente produce un aumento de la sedación.
  • No es posible realizar un adecuado balance entre beneficios y riesgos, debido a la incertidumbre asociada a los primeros. Sin embargo, considerando que no tiene beneficio clínicamente importante sobre el desenlace principal, y que tiene efectos adversos, probablemente se trata de una intervención cuyo balance es desfavorable. 
Consideraciones de recursos
  • Se trata de una intervención de relativo bajo costo en el contexto perioperatorio.
  • No es posible realizar un adecuado balance entre beneficios y costos, debido a la incertidumbre asociada a los primeros. Sin embargo, probablemente se trata de una intervención cuyo balance es desfavorable. 
Qué piensan los pacientes y sus tratantes
  • Frente a la evidencia presentada en este resumen la mayoría de los clínicos debiera inclinarse en contra de su utilización.
  • Podría esperarse variabilidad en la toma de decisión, dado que existe cierta posibilidad de beneficio, particularmente en el análisis de subgrupos y los efectos adversos no son severos. Esto podría verse aumentado por la existencia de recomendaciones a favor de esta intervención en las principales guías clínicas.
Diferencias entre este resumen y otras fuentes
  • Las conclusiones de este resumen concuerdan con las revisiones sistemáticas identificadas, las cuales plantean en que el uso de pregabalina podría tener algún rol en el manejo del dolor postoperatorio, pero que este es de bajo impacto y depende del tipo de cirugía. Su indicación para el uso rutinario es discutida y debiesen tomarse en cuenta los riesgos y beneficios asociados. Destacan, además, que la calidad de la evidencia existente es baja.
  • Respecto a las principales guías clínicas, las Practice Guidelines for Acute Pain Management in the Perioperative Setting de la American Society of Anesthesiologists refiere que la pregabalina debiera considerarse como parte de la analgesia multimodal postoperatoria, dado que se ha descrito reducción de dolor y del consumo de opioides postoperatorio [100]. Por otro lado, la guía Acute pain management: scientific evidence del Australian and New Zealand College of Anaesthetists (ANZCA) menciona a la pregabalina como parte de las opciones de tratamiento para el dolor neuropático agudo en el contexto de cirugía y trauma [101].
¿Puede que cambie esta información en el futuro?
  • La probabilidad de que futuras investigaciones cambien las conclusiones de este resumen es alta, debido a la incertidumbre asociada a algunos de los desenlaces.
  • En una búsqueda en el International prospective register of systematic reviews (PROSPERO),  identificamos al menos siete revisiones en curso que abordan esta pregunta [102],[103],[104],[105],[106],[107],[108]. Sus conclusiones podrían aportar nuevas luces sobre esta pregunta.
  • Además, existen al menos seis ensayos controlados aleatorizados en curso que evalúan el uso de pregabalina en el perioperatorio [109],[110],[111],[112],[113],[114], de acuerdo a la International Clinical Trials Registry Platform de la Organización Mundial de la Salud.
Cómo realizamos este resumen

Mediante métodos automatizados y colaborativos recopilamos toda la evidencia relevante para la pregunta de interés y la presentamos en una matriz de evidencia.

Siga el enlace para acceder a la versión interactiva: Pregabalina perioperatoria para el dolor postoperatorio agudo en cirugías mayores

Notas

Si con posterioridad a la publicación de este resumen se publican nuevas revisiones sistemáticas sobre este tema, en la parte superior de la matriz se mostrará un aviso de “nueva evidencia”. Si bien el proyecto contempla la actualización periódica de estos resúmenes, los usuarios están invitados a comentar en la página web de Medwave o contactar a los autores mediante correo electrónico si creen que hay evidencia que motive una actualización más precoz.

Luego de crear una cuenta en Epistemonikos, al guardar las matrices recibirá notificaciones automáticas cada vez que exista nueva evidencia que potencialmente responda a esta pregunta.

Este artículo es parte del proyecto síntesis de evidencia de Epistemonikos. Se elabora con una metodología preestablecida, siguiendo rigurosos estándares metodológicos y proceso de revisión por pares interno. Cada uno de estos artículos corresponde a un resumen, denominado FRISBEE (Friendly Summary of Body of Evidence using Epistemonikos), cuyo principal objetivo es sintetizar el conjunto de evidencia de una pregunta específica, en un formato amigable a los profesionales clínicos. Sus principales recursos se basan en la matriz de evidencia de Epistemonikos y análisis de resultados usando metodología GRADE. Mayores detalles de los métodos para elaborar este FRISBEE están descritos aquí (http://dx.doi.org/10.5867/medwave.2014.06.5997)

La Fundación Epistemonikos es una organización que busca acercar la información a quienes toman decisiones en salud, mediante el uso de tecnologías. Su principal desarrollo es la base de datos Epistemonikos (www.epistemonikos.org).

Declaración de conflictos de intereses

Los autores declaran no tener conflictos de intereses con la materia de este artículo.

Licencia Creative Commons Esta obra de Medwave está bajo una licencia Creative Commons Atribución-NoComercial 3.0 Unported. Esta licencia permite el uso, distribución y reproducción del artículo en cualquier medio, siempre y cuando se otorgue el crédito correspondiente al autor del artículo y al medio en que se publica, en este caso, Medwave.

 

INTRODUCTION
Pregabalin is a structural analog of γ-aminobutyric acid that may have a role in acute pain management. It has been used in the perioperative context, but there is controversy regarding its real clinical utility.

METHODS
To answer this question we used Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others. We extracted data from the systematic reviews, reanalyzed data of primary studies, conducted a meta-analysis and generated a summary of findings table using the GRADE approach.

RESULTS AND CONCLUSIONS
We identified 21 systematic reviews including 77 randomized trials. We concluded the use of perioperative pregabalin in major surgeries probably does not produce a clinically important decrease in acute postoperative pain. Although it could decrease nausea, postoperative vomiting and opioid requirements, it also produces an increase in sedation.

Autores: José Canihuante[1,2], Ian Molina[1,2], Fernando Altermatt[2,3]

Filiación:
[1] Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile
[2] Proyecto Epistemonikos, Santiago, Chile
[3] Departamento de Anestesiología, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile

E-mail: fernando.altermatt@gmail.com

Correspondencia a:
[1] Centro Evidencia UC
Pontificia Universidad Católica de Chile
Centro de Innovación UC Anacleto Angelini
Avda.Vicuña Mackenna 4860
Macul
Santiago
Chile

Citación: Canihuante J, Molina I, Altermatt F. Is perioperative pregabalin effective for reducing postoperative pain in major surgery?. Medwave 2017 Nov-Dic;17(9):e7115 doi: 10.5867/medwave.2017.09.7115

Fecha de envío: 23/11/2017

Fecha de aceptación: 20/12/2017

Fecha de publicación: 27/12/2017

Origen: Este artículo es producto del Epistemonikos Evidence Synthesis Project de la Fundación Epistemonikos, en colaboración con Medwave para su publicación.

Tipo de revisión: Con revisión por pares sin ciego por parte del equipo metodológico del Epistemonikos Evidence Synthesis Project.

Ficha PubMed

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