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- Ensaio Clínico NCT01291680
Assessment of Central Pain in the Peripartum Period
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.
Visão geral do estudo
Status
Descrição detalhada
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 estudo
Inscrição (Antecipado)
Contactos e Locais
Contato de estudo
- Nome: Jacob N Ablin, MD
- Número de telefone: 972-3-6973668
- E-mail: jacobab@tasmc.health.gov.il
Estude backup de contato
- Nome: Ariel Mani, MD
Locais de estudo
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Tel Aviv, Israel, 64239
- Tel Aviv Sourasky Medical Ceter
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Investigador principal:
- Jacob N Ablin, MD
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Contato:
- Jacob N Ablin, MD
- Número de telefone: 972-3-6973668
- E-mail: jacobab@tasmc.health.gov.il
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Patient Controlled Analgesia (PCA) use during delivery
Prazo: up to 3 days after delivery
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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/
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up to 3 days after delivery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Patient report of pain intensity during delivery
Prazo: up to 3 days after delivery
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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)
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up to 3 days after delivery
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Blood pressure and pulse recordings
Prazo: During labor
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Standard clinical recording of hemodynamic measurments during labor
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During labor
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Mode of delivery
Prazo: During labor
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Recording of mode of delivery, need for cessarian section etc
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During labor
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.
- Wolfe F, Ross K, Anderson J, Russell IJ, Hebert L. The prevalence and characteristics of fibromyalgia in the general population. Arthritis Rheum. 1995 Jan;38(1):19-28. doi: 10.1002/art.1780380104.
- Ablin K, Clauw DJ. From fibrositis to functional somatic syndromes to a bell-shaped curve of pain and sensory sensitivity: evolution of a clinical construct. Rheum Dis Clin North Am. 2009 May;35(2):233-51. doi: 10.1016/j.rdc.2009.06.006.
- Eisenberg E, McNicol ED, Carr DB. Efficacy and safety of opioid agonists in the treatment of neuropathic pain of nonmalignant origin: systematic review and meta-analysis of randomized controlled trials. JAMA. 2005 Jun 22;293(24):3043-52. doi: 10.1001/jama.293.24.3043.
- Cohen H, Neumann L, Shore M, Amir M, Cassuto Y, Buskila D. Autonomic dysfunction in patients with fibromyalgia: application of power spectral analysis of heart rate variability. Semin Arthritis Rheum. 2000 Feb;29(4):217-27. doi: 10.1016/s0049-0172(00)80010-4.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 0033-10-TLV
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