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Assessment of Central Pain in the Peripartum Period

7 de febrero de 2011 actualizado por: Tel-Aviv Sourasky Medical Center

Chronic pain is common. Up to 10% of the Population has been estimated to suffer from chronic pain and up to 5% of the female population has been estimated to suffer from widespread, chronic pain and tenderness, thus fulfilling American College of Rheumatology (ACR) criteria for classification of fibromyalgia syndrome (FMS). FMS is characterized by the presence of both allodynia and hyperalgesia. FMS is also characterized by disturbances of the autonomic nervous system such as orthostatic intolerance, postural tachycardia etc. The effect of these conditions during gestation and post partum periods is not well known.

Parturition is a complex process which involves multiple endocrine and physiological changes within a short period of time. Severe pain is an important attribute of this natural process. The purpose of the current study is to evaluate the impact of chronic central pain on the process of parturition. Our hypothesis is, that women demonstrating signs, symptoms and a history of central pain, before the onset of active labor, will differ from women not demonstrating such traits; these women may require earlier higher does of analgesia, and may demonstrate increased hemodynamic lability during labor and delivery.

Descripción general del estudio

Descripción detallada

Chronic pain is common. Up to 10% of the Population has been estimated to suffer from chronic pain and up to 5% of the female population has been estimated to suffer from widespread, chronic pain and tenderness, thus fulfilling American College of Rheumatology (ACR) criteria for classification of fibromyalgia syndrome (FMS)(1;2). FMS is considered to represent a prototype of chronic pain which is mediated by the central nervous system, i.e. a condition in which chronic pain is the result of augmented pain processing (and diminished pain - inhibition) within the Central Nercous System (CNS) circuitry (3). Clinical characteristics which are suggestive of the presence of central, versus peripheral (nociceptive) or neuropathic pain, are a lifetime history of pain conditions, a diffuse, non- anatomical distribution of pain, a family history of chronic pain and the co-existence of additional "functional" symptoms such as chronic fatigue, disturbed sleep, irritable bowel etc.

The current paradigms accepted for the pathogenesis of central pain involve an imbalance of multiple neurotransmitters in the CNS, some inhibitory (e.g. serotonin, norepinephrine) others facilitatory (e.g. substance P) which govern the process of spinal pain transmission. Additional processing takes place at higher centers, such as the amygdala and thalamus (4).

FMS is characterized by the presence of both allodynia and hyperalgesia. In addition, medications which have been shown to be effective in FMS and similar conditions are different from those effective in acute pain or in other chronic pain conditions not characterized as central (e.g. malignancy - associated pain). Thus, opioids and Non Steroidal Anti-Inflammatory Drugs (NSAIDS) are relatively ineffective for the treatment of central pain (the former may even cause paradoxical hyperalgesia) (5) while medications which increase levels of norepinephrine and serotonin (NSRIs) are often effective. FMS is also characterized by disturbances of the autonomic nervous system such as orthostatic intolerance, postural tachycardia etc.(6) The effect of these conditions during gestation and post partum periods is not well known.

Parturition is a complex process which involves multiple endocrine and physiological changes within a short period of time. Severe pain is an important attribute of this natural process. The processes of labor, delivery and also the peripartum period are characterized by acute shifts in volume, loss of blood and additional forms of physiological stress and emotional distress.

The purpose of the current study is to evaluate the impact of chronic central pain on the process of parturition. Our hypothesis is, that women demonstrating signs, symptoms and a history of central pain, before the onset of active labor, will differ from women not demonstrating such traits; these women may require earlier higher does of analgesia, and may demonstrate increased hemodynamic lability during labor and delivery.

Tipo de estudio

De observación

Inscripción (Anticipado)

100

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Ceter

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Femenino

Método de muestreo

Muestra no probabilística

Población de estudio

The study will be conducted as an open label, observational research. The setting of the study is the Obstetric ER of the Lis Maternity Hospital, Tel Aviv sourasky medical center.

Participants in the study will be pregnant women attending the obstetric ER for routine term followup. This evaluation is generally conducted at week 39-41 of pregnancy. The current study will focus on women attending a regular followup, not considered to be at high risk.

All participants will be requested to sign written informed consent on recruitment.

Descripción

Inclusion Criteria:

  • Pregnant women, week 39-41
  • Ability to give written informed consent

Exclusion Criteria:

  • Age under 18
  • High risk pregnancy
  • Not able to give written informed consent

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Pre - delivery pregnant women
Participants in the study will be pregnant women attending the obstetric ER for routine term followup. This evaluation is generally conducted at week 39-41 of pregnancy. The current study will focus on women attending a regular followup, not considered to be at high risk.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient Controlled Analgesia (PCA) use during delivery
Periodo de tiempo: up to 3 days after delivery
Use of anagesics (i.e. PCA) during and after delivery will be documented and compared with results of evaluation performed before delivery regarding tenderness, symptoms of fibromyalgia etc/
up to 3 days after delivery

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient report of pain intensity during delivery
Periodo de tiempo: up to 3 days after delivery
Information will be collected regarding pain levels during delivery, regarding hemodynamic changes during delivery, regarding the mode of delivery as well as standard neonatal data (APGAR score etc)
up to 3 days after delivery
Blood pressure and pulse recordings
Periodo de tiempo: During labor
Standard clinical recording of hemodynamic measurments during labor
During labor
Mode of delivery
Periodo de tiempo: During labor
Recording of mode of delivery, need for cessarian section etc
During labor

Colaboradores e Investigadores

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Publicaciones y enlaces útiles

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Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de marzo de 2011

Finalización primaria (Anticipado)

1 de marzo de 2013

Finalización del estudio (Anticipado)

1 de septiembre de 2013

Fechas de registro del estudio

Enviado por primera vez

2 de febrero de 2011

Primero enviado que cumplió con los criterios de control de calidad

7 de febrero de 2011

Publicado por primera vez (Estimar)

8 de febrero de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

8 de febrero de 2011

Última actualización enviada que cumplió con los criterios de control de calidad

7 de febrero de 2011

Última verificación

1 de febrero de 2011

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 0033-10-TLV

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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