Perfusion Index and Labor Analgesia

May 20, 2017 updated by: ILKE KUPELI, Erzincan University

Can the Perfusion Index be Used as an Objective Instrument for the Assessment of Pain in the Labor Analgesia?

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Erzincan, Turkey
        • Recruiting
        • Erzincan University
        • Contact:
          • ufuk kuyrukluyıldız
          • Phone Number: +904462122222

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

30 women between the ages of 18-45 who will give normal spontaneous vaginal delivery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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,
three month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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,
three month
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,
three month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erzincan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 30, 2017

Primary Completion (Anticipated)

July 15, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

April 5, 2017

First Submitted That Met QC Criteria

April 5, 2017

First Posted (Actual)

April 11, 2017

Study Record Updates

Last Update Posted (Actual)

May 23, 2017

Last Update Submitted That Met QC Criteria

May 20, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERZINCAN UNIVERSITY pain&pi

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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