Effect of Thoracic Paravertebral Block on Heart Rate Variability (HRV)
1 other identifier
observational
100
1 country
1
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
Trial Health
Trial Health Score
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participants targeted
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Started Dec 2014
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2012
CompletedFirst Posted
Study publicly available on registry
December 24, 2012
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedJuly 10, 2014
July 1, 2014
1 year
December 19, 2012
July 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of thoracic paravertebral block on Heart Rate Variability (HRV)
The Left thoracic paravertebral block has different effect on heart's autonomic nervous system, as measured with HRV, than the Right.
30 min after the application of the thoracic paravertebral block
Study Arms (2)
Left thoaracic paravertebral block
Surgery in the left breast under left thoracic paravertebral block and HRV
Right thoracic paravertebral block and HRV
Surgery in the right breast under right thoracic paravertebral block and HRV
Interventions
Eligibility Criteria
Patients for elective breast surgery
You may qualify if:
- Elective breast surgery
- Age 20 - 65 years
- ASA I - II
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Larissa University Hospital
Larissa, Thessally, 41110, Greece
Study Officials
- PRINCIPAL INVESTIGATOR
Marina Simaioforidou, Medicine
Larissa University Hospital
- STUDY DIRECTOR
George Vretzakis, Medicine
Larissa University Hospital
- STUDY CHAIR
Aikaterini Tsiaka, Medicine
Larissa University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiologist
Study Record Dates
First Submitted
December 19, 2012
First Posted
December 24, 2012
Study Start
December 1, 2014
Primary Completion
December 1, 2015
Study Completion
July 1, 2016
Last Updated
July 10, 2014
Record last verified: 2014-07