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

NCT ID: NCT01755910

Last Updated: 2014-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-07-31

Brief Summary

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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

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Conditions

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Breast Surgery Thoracic Paravertebral Block HRV Autonomic Nervous System

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Left thoaracic paravertebral block

Surgery in the left breast under left thoracic paravertebral block and HRV

Left thoracic paravertebral block

Intervention Type OTHER

Right thoracic paravertebral block and HRV

Surgery in the right breast under right thoracic paravertebral block and HRV

Right thoracic paravertebral block

Intervention Type OTHER

Interventions

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Left thoracic paravertebral block

Intervention Type OTHER

Right thoracic paravertebral block

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Larissa University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Marina Simaioforidou

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marina Simaioforidou, Medicine

Role: PRINCIPAL_INVESTIGATOR

Larissa University Hospital

George Vretzakis, Medicine

Role: STUDY_DIRECTOR

Larissa University Hospital

Aikaterini Tsiaka, Medicine

Role: STUDY_CHAIR

Larissa University Hospital

Locations

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Larissa University Hospital

Larissa, Thessally, Greece

Site Status

Countries

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Greece

Central Contacts

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Marina Simaioforidou, Medicine

Role: CONTACT

00306972202573

George Vretzakis, Medicine

Role: CONTACT

00302413502952 ext. 2952

Facility Contacts

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George Vretzakis, Medicine

Role: primary

00302413502952 ext. 2952

Other Identifiers

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HRV Thoracic paravertebral

Identifier Type: -

Identifier Source: org_study_id

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