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

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ClinicalTrials.gov Identifier: NCT01755910
Recruitment Status : Unknown
Verified July 2014 by Marina Simaioforidou, Larissa University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 24, 2012
Last Update Posted : July 10, 2014
Sponsor:
Information provided by (Responsible Party):
Marina Simaioforidou, Larissa University Hospital

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment
Breast Surgery Thoracic Paravertebral Block HRV Autonomic Nervous System Other: Left thoracic paravertebral block Other: Right thoracic paravertebral block

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effect of Thoracic Paravertebral Block on the Autonomous System as Measured by Heart Rate Variability (HRV)
Study Start Date : December 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : July 2016
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients for elective breast surgery
Criteria

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
Contacts and Locations
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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): NCT01755910


Contacts
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Contact: Marina Simaioforidou, Medicine 00306972202573 msimaiof@otenet.gr
Contact: George Vretzakis, Medicine 00302413502952 ext 2952 gvretzakis@yahoo.com

Locations
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Greece
Larissa University Hospital
Larissa, Thessally, Greece, 41110
Contact: George Vretzakis, Medicine    00302413502952 ext 2952    gvretzakis@yahoo.com   
Sponsors and Collaborators
Larissa University Hospital
Investigators
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Principal Investigator: Marina Simaioforidou, Medicine Larissa University Hospital
Study Director: George Vretzakis, Medicine Larissa University Hospital
Study Chair: Aikaterini Tsiaka, Medicine Larissa University Hospital
More Information
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Responsible Party: Marina Simaioforidou, Anesthesiologist, Larissa University Hospital
ClinicalTrials.gov Identifier: NCT01755910    
Other Study ID Numbers: HRV Thoracic paravertebral
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: July 10, 2014
Last Verified: July 2014
Keywords provided by Marina Simaioforidou, Larissa University Hospital:
Breast Surgery
Thoracic Paravertebral Block
HRV
Autonomic Nervous System
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases