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

• Conditions: HRV; Autonomic Nervous System; Thoracic Paravertebral Block; Breast Surgery
• Interventions: Other: Left thoracic paravertebral block; Other: Right thoracic paravertebral block

• Registration Number: NCT01755910
• Lead Sponsor: Larissa University Hospital

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 available

Study Timeline

• Study First Submitted: 2012-12-19
• Study First Submitted QC: 2012-12-19
• Study First Posted: 2012-12-24
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-09
• Last Update Posted: 2014-07-10
• Study Start: 2014-12
• Primary Completion: 2015-12
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Left thoaracic paravertebral block	Left thoracic paravertebral block	Surgery in the left breast under left thoracic paravertebral block and HRV
Right thoracic paravertebral block and HRV	Right thoracic paravertebral block	Surgery in the right breast under right thoracic paravertebral block and HRV

Primary Outcome Measures

Name	Time	Method
Effect of thoracic paravertebral block on Heart Rate Variability (HRV)	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.

Trial Locations

Locations (1)

Larissa University Hospital; 🇬🇷 Larissa, Thessally, Greece