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OpenTrials
Completed

NCT Number: NCT01185457

Effect of Interscalene Block on Heart Rate Variability (HRV)

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

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Key information

Conditions

Shoulder Surgery Autonomic Nervous System Beach Chair Position HRV Interscalene Block

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Larissa University Hospital

Larissa, Thessaly, 41110, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Interscalene block and beach chair positioning

    Time frame: 2 years

    Effect of interscalene block on hypotension during beach chair positioning

  2. Interscalene block and beach chair positioning

    Time frame: 2 years

    Effect of interscalene block on bradycardia during beach chair positioning

Sponsors and collaborators

Lead sponsor

Larissa University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 20, 2010
Registry last updated
Oct 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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