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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 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: July 9, 2014
Last verified: July 2014
  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: December 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: December 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 9, 2014
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 August 21, 2014