Assessment of Central Pain in the Peripartum Period
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Purpose
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.
| Condition |
|---|
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Pre - Delivery Pregnant Women Chronic Pain Pain During Delivery |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Assessment of Central Pain in the Peripartum Period |
- Patient Controlled Analgesia (PCA) use during delivery [ Time Frame: up to 3 days after delivery ] [ Designated as safety issue: No ]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/
- Patient report of pain intensity during delivery [ Time Frame: up to 3 days after delivery ] [ Designated as safety issue: No ]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)
- Blood pressure and pulse recordings [ Time Frame: During labor ] [ Designated as safety issue: No ]Standard clinical recording of hemodynamic measurments during labor
- Mode of delivery [ Time Frame: During labor ] [ Designated as safety issue: No ]Recording of mode of delivery, need for cessarian section etc
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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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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Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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
Contacts and Locations| Contact: Jacob N Ablin, MD | 972-3-6973668 | jacobab@tasmc.health.gov.il |
| Contact: Ariel Mani, MD |
| Israel | |
| Tel Aviv Sourasky Medical Ceter | Not yet recruiting |
| Tel Aviv, Israel, 64239 | |
| Contact: Jacob N Ablin, MD 972-3-6973668 jacobab@tasmc.health.gov.il | |
| Principal Investigator: Jacob N Ablin, MD | |
More Information
Publications:
| Responsible Party: | Jacob N Ablin MD, Tel Aviv Souraski Medical Center |
| ClinicalTrials.gov Identifier: | NCT01291680 History of Changes |
| Other Study ID Numbers: | 0033-10-TLV |
| Study First Received: | February 2, 2011 |
| Last Updated: | February 7, 2011 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Tel-Aviv Sourasky Medical Center:
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Pregnancy Chronic pain Fibromyalgia |
ClinicalTrials.gov processed this record on May 19, 2013