Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Assessment of Central Pain in the Peripartum Period

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01291680
First received: February 2, 2011
Last updated: February 7, 2011
Last verified: February 2011
  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
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

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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/


Secondary Outcome Measures:
  • 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
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.

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
Study Population

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291680

Contacts
Contact: Jacob N Ablin, MD 972-3-6973668 jacobab@tasmc.health.gov.il
Contact: Ariel Mani, MD

Locations
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         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
  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:
Pregnancy
Chronic pain
Fibromyalgia

Additional relevant MeSH terms:
Chronic Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014