Assessment of Central Pain in the Peripartum Period

NCT01291680 | Unknown

• 1 other identifier: 0033-10-TLV
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pre - Delivery Pregnant Women; Chronic Pain; Pain During Delivery

Keywords

Pregnancy; Chronic pain; Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Patient Controlled Analgesia (PCA) use during 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

Secondary Outcomes (3)

• Patient report of pain intensity during delivery

  up to 3 days after delivery

• Blood pressure and pulse recordings

  During labor

• Mode of delivery

  During labor

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky Medical Ceter

Tel Aviv, Israel, 64239, Israel

Location

Related Publications (5)

• 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.

  PMID: 7818567 BACKGROUND

• 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.

  PMID: 2306288 BACKGROUND

• 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.

  PMID: 19647139 BACKGROUND

• 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.

  PMID: 15972567 BACKGROUND

• 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.

  PMID: 10707990 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Fibromyalgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Jacob N Ablin, MD

CONTACT

972-3-6973668; jacobab@tasmc.health.gov.il

Ariel Mani, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: February 2, 2011
• First Posted: February 8, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 8, 2011

Record last verified: 2011-02

Locations

IL (1)