Effect of Thoracic Paravertebral Block on Heart Rate Variability (HRV)

July 9, 2014 updated by: Marina Simaioforidou, Larissa University Hospital

Effect of Thoracic Paravertebral Block on the Autonomous System as Measured by Heart Rate Variability (HRV)

The Left thoracic paravertebral block have a different effect on heart's autonomic nervous system, as measured with Heart Rate Variability, compared to Right interscalene block

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

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

Study Locations

  • Greece
    • Thessally
      • Larissa, Thessally, Greece, 41110
        • Larissa University Hospital

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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients for elective breast surgery

Description

Inclusion Criteria:

  • Elective breast surgery
  • Age 20 - 65 years
  • ASA I - II

Exclusion Criteria:

  • Coagulopathy disorders
  • Infection at the puncture site for the thoracic paravertebral block
  • Severe kyphoscoliosis
  • Allergy to local anesthetics
  • BMI > 35
  • Psychiatric disorders
  • Patient's refusal
  • Problems with patient communication
  • Arrythmia
  • Ischaemic heart disease
  • Diabetes mellitus
  • Thyroid function disorders
  • Patients with conduction disorders on the ECG
  • Electrolyte disorders (K+, Na+, Ca++)
  • Patients on medication that affect the ECG

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Left thoaracic paravertebral block
Surgery in the left breast under left thoracic paravertebral block and HRV
Other: Left thoracic paravertebral block
Right thoracic paravertebral block and HRV
Surgery in the right breast under right thoracic paravertebral block and HRV
Other: Right thoracic paravertebral block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of thoracic paravertebral block on Heart Rate Variability (HRV)
Time Frame: 30 min after the application of the thoracic paravertebral block
The Left thoracic paravertebral block has different effect on heart's autonomic nervous system, as measured with HRV, than the Right.
30 min after the application of the thoracic paravertebral block

Collaborators and Investigators

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

Sponsor

Larissa University Hospital

Investigators

  • Principal Investigator: Marina Simaioforidou, Medicine, Larissa University Hospital
  • Study Director: George Vretzakis, Medicine, Larissa University Hospital
  • Study Chair: Aikaterini Tsiaka, Medicine, Larissa University Hospital

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

December 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

December 19, 2012

First Submitted That Met QC Criteria

December 19, 2012

First Posted (Estimate)

December 24, 2012

Study Record Updates

Last Update Posted (Estimate)

July 10, 2014

Last Update Submitted That Met QC Criteria

July 9, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRV Thoracic paravertebral

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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