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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by Larissa University Hospital.
Recruitment status was:  Not yet recruiting
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   (Adult)
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

Locations
Greece
Larissa University Hospital
Larissa, Thessally, Greece, 41110
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

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 December 02, 2016