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

Autonomic Nervous System Clinical Trial

Official title:

Effect of Thoracic Paravertebral Block on the Autonomous System as Measured by Heart Rate Variability (HRV)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01755910
• Other study ID #: HRV Thoracic paravertebral
• Status: Not yet recruiting
• Phase: N/A
• First received: December 19, 2012
• Last updated: July 9, 2014
• Start date: December 2014
• Est. completion date: July 2016

Study information

• Verified date: July 2014
• Source: Larissa University Hospital
• Contact: Marina Simaioforidou, Medicine
• Phone: 00306972202573
• Email: msimaiof[@]otenet.gr
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Autonomic Nervous System
• Breast Surgery
• HRV
• Thoracic Paravertebral Block

Intervention

Other:
• Left thoracic paravertebral block

• Right thoracic paravertebral block

Locations

Country	Name	City	State
Greece	Larissa University Hospital	Larissa	Thessally

Sponsors (1)

Lead Sponsor	Collaborator
Larissa University Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No