Effect of Interscalene Block on Heart Rate Variability (HRV)

October 26, 2012 updated by: Eleni Chantzi, Larissa University Hospital

Effect of Interscalene Block on Heart's Autonomic Nervous System With Heart Rate Variability Measurement

The Left interscalene block has a different effect on heart's autonomic nervous system, as measured with Heart Rate Variability, compared to Right interscalene block

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Thessaly
      • Larissa, Thessaly, Greece, 41110
        • Larissa University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients for elective shoulder surgery

Description

Inclusion Criteria:

  • elective shoulder surgery
  • Age 20- 45 years old
  • ASA I - II

Exclusion Criteria:

  • Coagulopathy disorders
  • Infection at the puncture site for the interscalene block
  • Neurologic deficit in the arm that is going to be operated
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Left interscalene block
Left shoulder surgery under left interscalene block and HRV
Right interscalene block
Right shoulder surgery under right interscalene block and HRV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of interscalene block on Heart Rate Variability (HRV)
Time Frame: 1 year
The Left interscalene block has different effect on heart's autonomic nervous system, as measured with HRV, than the Right.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interscalene block and beach chair positioning
Time Frame: 2 years
Effect of interscalene block on hypotension during beach chair positioning
2 years
Interscalene block and beach chair positioning
Time Frame: 2 years
Effect of interscalene block on bradycardia during beach chair positioning
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Larissa University Hospital

Investigators

  • Study Chair: Marina Simaioforidou, Medicine, Larissa University Hospital
  • Study Chair: Metaxia Bareka, Medicine, Larissa University Hospital
  • Study Director: George Vretzakis, Medicine, Larissa University Hospital
  • Principal Investigator: Eleni Chantzi, Medicine, Larissa University Hospital
  • Study Chair: Christos Iatrou, Medicine, Alexandroupoli University Hospital
  • Study Chair: Theophilos Karachalios, Medicine, Larissa University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

August 18, 2010

First Submitted That Met QC Criteria

August 19, 2010

First Posted (Estimate)

August 20, 2010

Study Record Updates

Last Update Posted (Estimate)

October 29, 2012

Last Update Submitted That Met QC Criteria

October 26, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HRVShoulder

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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