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Perfusion Index and Labor Analgesia

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ClinicalTrials.gov Identifier: NCT03107559
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
ILKE KUPELI, Erzincan University

Brief Summary:
It can be suggested that sympathetic tonus increase and pain, caused by the removal of the effect of epidural analgesia applied at birth, may also affect perfüsion index. The purpose of this study is; To correlate the VAS value at the time of return of epidural analgesia with the PI values at that time and, to test the possibility of using PI variants as an objective tool for predicting pain initiation time and assessing pain.

Condition or disease Intervention/treatment
perfüsion Index in Removal of the Epidural Analgesia Diagnostic Test: perfüsion index

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Can the Perfusion Index be Used as an Objective Instrument for the Assessment of Pain in the Labor Analgesia?
Estimated Study Start Date : May 30, 2017
Estimated Primary Completion Date : July 15, 2017
Estimated Study Completion Date : August 1, 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: perfüsion index
    Determination of the relationship between VAS values and PI in patients with normal delivery who undergo epidural analgesia


Primary Outcome Measures :
  1. relationship between Visual analogue scale and Perfüsion index [ Time Frame: three month ]
    Determination of the relationship between VAS values and PI in patients with normal delivery who undergo epidural analgesia,


Secondary Outcome Measures :
  1. relationship between heart rate and Perfüsion index [ Time Frame: three month ]
    Determination of the relationship between heart rate and PI in patients with normal delivery who undergo epidural analgesia,

  2. relationship between non-invazive blood pressure and Perfüsion index [ Time Frame: three month ]
    Determination of the relationship between non-invazive blood pressure and PI in patients with normal delivery who undergo epidural analgesia,



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
30 women between the ages of 18-45 who will give normal spontaneous vaginal delivery
Criteria

Inclusion Criteria:

  • women who will give normal spontaneous vaginal delivery
  • Between the ages of 18-45

Exclusion Criteria:

  • Patients who do not accept the procedure,
  • those under 18 years of age - over 45 years,
  • those with low platelet counts,
  • those with infection at the puncture site,
  • those with progressive neurological disease,
  • Those with increased intracranial pressure,
  • those with hypovolemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107559


Contacts
Contact: ilke kupeli 5555485632 ilkeser2004@gmail.com

Locations
Turkey
Erzincan University Recruiting
Erzincan, Turkey
Contact: ufuk kuyrukluyıldız    +904462122222      
Sponsors and Collaborators
Erzincan University
Investigators
Principal Investigator: ilke kupeli Erzincan University

Publications of Results:
Other Publications:
Responsible Party: ILKE KUPELI, assist. prof., Erzincan University
ClinicalTrials.gov Identifier: NCT03107559     History of Changes
Other Study ID Numbers: ERZINCAN UNIVERSITY pain&pi
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ILKE KUPELI, Erzincan University:
perfüsion index
epidural analgesia
labor

Additional relevant MeSH terms:
Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms