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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

Tracking Information
First Submitted Date December 19, 2012
First Posted Date December 24, 2012
Last Update Posted Date July 10, 2014
Study Start Date December 2014
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 19, 2012)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Thoracic Paravertebral Block on Heart Rate Variability (HRV)
Official Title Effect of Thoracic Paravertebral Block on the Autonomous System as Measured by Heart Rate Variability (HRV)
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients for elective breast surgery
Condition
  • Breast Surgery
  • Thoracic Paravertebral Block
  • HRV
  • Autonomic Nervous System
Intervention
  • Other: Left thoracic paravertebral block
  • Other: Right thoracic paravertebral block
Study Groups/Cohorts
  • Left thoaracic paravertebral block
    Surgery in the left breast under left thoracic paravertebral block and HRV
    Intervention: Other: Left thoracic paravertebral block
  • Right thoracic paravertebral block and HRV
    Surgery in the right breast under right thoracic paravertebral block and HRV
    Intervention: Other: Right thoracic paravertebral block
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 19, 2012)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2016
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Greece
Removed Location Countries  
 
Administrative Information
NCT Number NCT01755910
Other Study ID Numbers HRV Thoracic paravertebral
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Marina Simaioforidou, Larissa University Hospital
Study Sponsor Larissa University Hospital
Collaborators Not Provided
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
PRS Account Larissa University Hospital
Verification Date July 2014