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Completed

NCT Number: NCT03514342

The Effects of Horner's Syndrome Developing After Interscalene Brachial Plexus Block on Autonomic Nervous Activity

This study evaluates the effects of Horner's syndrome on cardiac autonomic nervous activity after interscalene brachial plexus block. Cardiac autonomic nervous activity and bilateral pupil diameters will be measured in a scotopic light condition, 30 minutes after interscalene brachial plexus block under ultrasound guidance and 15 minutes after the subsequent sitting position.

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Key information

Conditions

Brachial Plexus Block Autonomic Imbalance Autonomic Nervous System Diseases Brain Diseases Cavernous Sinus Syndromes Central Nervous System Diseases Eye Diseases Horner Syndrome Miosis Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Pupil Disorders Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

About this study

Stellate ganglia provide sympathetic fibers to the heart. Ipsilateral stellate ganglion block accompanied by interscalene brachial plexus block causes Horner's syndrome presenting with miosis, ptosis, and anhidrosis. The extent of Horner's syndrome can be represented by the difference in pupil diameter between bilateral eyes. Cardiac autonomic nervous activity affected by stellate ganglion block can be measured by calculation of heart rate variability parameters.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologists physical status 1
  • Arthroscopic shoulder surgery under interscalene brachial plexus block

Exclusion criteria

  • Coagulopathy
  • Infection at the site of brachial plexus block
  • Peripheral neuropathy or neurologic sequelae on the operative limb
  • Allergy to local anesthetics or history of allergic shock
  • Psychiatric diseases
  • Patient refusal
  • Difficulty communicating with medical personnel
  • Arrhythmias
  • Ischemic heart disease
  • Hypertension
  • Diabetes mellitus
  • Thyroid dysfunction
  • Conduction abnormalities on electrocardiogram
  • Electrolyte imbalance
  • Medications affecting cardiac conduction
  • Contralateral vocal cord palsy
  • Contralateral hemidiaphragmatic paresis or paralysis
  • Contralateral pneumothorax or hemothorax

Treatment and study plan

Interscalene brachial plexus block

Procedure

Under ultrasound guidance, the 5th to 7th cervical nerve roots are identified between anterior and middle scalene muscles and subsequently blocked.

0.75% Ropivacaine

Drug

Placement of 25 to 30 ml of 0.75% ropivacaine around the 5th to 7th cervical nerve roots

Other names: Naropin

Primary outcomes

  1. Post-sitting sympathetic nervous activity

    Time frame: 15 minutes after the sitting position following interscalene brachial plexus block

    Natural-log transformed low frequency power of heart rate variability calculated using R wave to R wave intervals obtained for 5 minutes between 10 and 15 minutes after the sitting position following interscalene brachial plexus block

Secondary outcomes

  1. Post-sitting ipsilateral pupil diameter

    Time frame: 15 minutes after the sitting position following interscalene brachial plexus block

    Ipsilateral pupil diameter measured under a mesopic condition 15 minutes after the sitting position following interscalene brachial plexus block

  2. Post-sitting contralateral pupil diameter

    Time frame: 15 minutes after the sitting position following interscalene brachial plexus block

    Contralateral pupil diameter measured under a mesopic condition 15 minutes after the sitting position following interscalene brachial plexus block

  3. Post-anesthetic ipsilateral pupil diameter

    Time frame: 30 minutes after interscalene brachial plexus block

    Ipsilateral pupil diameter measured under a mesopic condition 30 minutes after interscalene brachial plexus block

  4. Post-anesthetic contralateral pupil diameter

    Time frame: 30 minutes after interscalene brachial plexus block

    Contralateral pupil diameter measured under a mesopic condition 30 minutes after interscalene brachial plexus block

  5. Pre-anesthetic ipsilateral pupil diameter

    Time frame: 15 minutes after baseline acclimation

    Ipsilateral pupil diameter measured under a mesopic condition 15 minutes after baseline acclimation

  6. Pre-anesthetic contralateral pupil diameter

    Time frame: 15 minutes after baseline acclimation

    Contralateral pupil diameter measured under a mesopic condition 15 minutes after baseline acclimation

  7. Post-sitting parasympathetic nervous activity

    Time frame: 15 minutes after the sitting position following interscalene brachial plexus block

    Natural-log transformed high frequency power of heart rate variability calculated using R wave to R wave intervals obtained for 5 minutes between 10 and 15 minutes after the sitting position following interscalene brachial plexus block

  8. Post-sitting sympathovagal balance

    Time frame: 15 minutes after the sitting position following interscalene brachial plexus block

    Low-to-high frequency power ratio of heart rate variability obtained for 5 minutes between 10 and 15 minutes after the sitting position following interscalene brachial plexus block

  9. Post-sitting overall variability of autonomic nervous system

    Time frame: 15 minutes after the sitting position following interscalene brachial plexus block

    Natural-log transformed total power of heart rate variability obtained for 5 minutes between 10 and 15 minutes after the sitting position following interscalene brachial plexus block

  10. Post-anesthetic sympathetic nervous activity

    Time frame: Between 25 and 30 minutes after interscalene brachial plexus block

    Natural-log transformed low frequency power of heart rate variability between 25 and 30 minutes after interscalene brachial plexus block

  11. Post-anesthetic parasympathetic nervous activity

    Time frame: Between 25 and 30 minutes after interscalene brachial plexus block

    Natural-log transformed high frequency power of heart rate variability between 25 and 30 minutes after interscalene brachial plexus block

  12. Post-anesthetic sympathovagal balance

    Time frame: Between 25 and 30 minutes after interscalene brachial plexus block

    Low-to-high frequency power ratio of heart rate variability between 25 and 30 minutes after interscalene brachial plexus block

  13. Post-anesthetic overall variability of autonomic nervous system

    Time frame: Between 25 and 30 minutes after interscalene brachial plexus block

    Natural-log transformed total power of heart rate variability between 25 and 30 minutes after interscalene brachial plexus block

  14. Pre-anesthetic sympathetic nervous activity

    Time frame: 15 minutes after baseline acclimiation

    Natural-log transformed low frequency power of heart rate variability 15 minutes after baseline acclimation

  15. Pre-anesthetic parasympathetic nervous activity

    Time frame: 15 minutes after baseline acclimiation

    Natural-log transformed high frequency power of heart rate variability 15 minutes after baseline acclimation

  16. Pre-anesthetic sympathovagal balance

    Time frame: 15 minutes after baseline acclimiation

    Low-to-high frequency power ratio of heart rate variability 15 minutes after baseline acclimation

  17. Pre-anesthetic overall variability of autonomic nervous system

    Time frame: 15 minutes after baseline acclimation

    Natural-log transformed total power of heart rate variability 15 minutes after baseline acclimation

  18. Sensory blockade

    Time frame: 30 minutes after interscalene brachial plexus block

    C5 to T1 dermatomal blockade of the shoulder graded from 0 to 2 (0 = no cold sensation, 1 = reduced cold sensation, and 2 = normal cold sensation) by applying ice to the shoulder

  19. Motor blockade

    Time frame: 30 minutes after interscalene brachial plexus block

    Motor blockade of the radial, ulnar, median, musculocutaneous, and axillary nerves graded from 0 to 2 (0 = no block 1 = partial block, and 2 = complete block)

Sponsors and collaborators

Lead sponsor

Daegu Catholic University Medical Center

Other

Collaborators

  • Research Institute of Medical Science, Daegu Catholic University

Registry information

Official study title

The Effects of Difference in Pupil Size Between Bilateral Eyes on Cardiac Sympathetic Nervous Activity Following Interscalene Brachial Plexus Block

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 2, 2018
Registry last updated
Jun 18, 2021

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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