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

This study is not yet open for participant recruitment.
Verified December 2013 by Larissa University Hospital
Sponsor:
Information provided by (Responsible Party):
Marina Simaioforidou, Larissa University Hospital
ClinicalTrials.gov Identifier:
NCT01755910
First received: December 19, 2012
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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 Intervention
Breast Surgery
Thoracic Paravertebral Block
HRV
Autonomic Nervous System
Other: Left thoracic paravertebral block
Other: Right thoracic paravertebral block

Study Type: Observational
Study Design: 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)

Further study details as provided by Larissa University Hospital:

Primary Outcome Measures:
  • Effect of thoracic paravertebral block on Heart Rate Variability (HRV) [ Time Frame: 30 min after the application of the thoracic paravertebral block ] [ Designated as safety issue: No ]
    The Left thoracic paravertebral block has different effect on heart's autonomic nervous system, as measured with HRV, than the Right.


Estimated Enrollment: 100
Study Start Date: May 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01755910

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

Locations
Greece
Larissa University Hospital Not yet recruiting
Larissa, Thessally, Greece, 41110
Contact: George Vretzakis, Medicine    00302413502952 ext 2952    gvretzakis@yahoo.com   
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Marina Simaioforidou, Anesthesiologist, Larissa University Hospital
ClinicalTrials.gov Identifier: NCT01755910     History of Changes
Other Study ID Numbers: HRV Thoracic paravertebral
Study First Received: December 19, 2012
Last Updated: December 4, 2013
Health Authority: Greece: National Organization of Medicines

Keywords provided by Larissa University Hospital:
Breast Surgery
Thoracic Paravertebral Block
HRV
Autonomic Nervous System

ClinicalTrials.gov processed this record on April 17, 2014