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

Sponsor
Daegu Catholic University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03514342
Collaborator
Research Institute of Medical Science, Daegu Catholic University (Other)
48
Enrollment
1
Location
12.4
Actual Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Interscalene brachial plexus block
  • Drug: 0.75% ropivacaine

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
48 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effects of Difference in Pupil Size Between Bilateral Eyes on Cardiac Sympathetic Nervous Activity Following Interscalene Brachial Plexus Block
Actual Study Start Date :
Jun 18, 2018
Actual Primary Completion Date :
Jul 1, 2019
Actual Study Completion Date :
Jul 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Interscalene brachial plexus block

Ultrasound-guided interscalene brachial plexus block with 25 ml to 30 ml of 0.75% ropivacaine

Procedure: Interscalene brachial plexus block
Under ultrasound guidance, the 5th to 7th cervical nerve roots are identified between anterior and middle scalene muscles and subsequently blocked.

Drug: 0.75% ropivacaine
Placement of 25 to 30 ml of 0.75% ropivacaine around the 5th to 7th cervical nerve roots
Other Names:
  • Naropin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Post-sitting sympathetic nervous activity [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 Outcome Measures

    1. Post-sitting ipsilateral pupil diameter [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 [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 [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 [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 [15 minutes after baseline acclimation]

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

    6. Pre-anesthetic contralateral pupil diameter [15 minutes after baseline acclimation]

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

    7. Post-sitting parasympathetic nervous activity [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [15 minutes after baseline acclimation]

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

    18. Sensory blockade [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 [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Daegu Catholic University Medical Center Daegu Korea, Republic of 42472

    Sponsors and Collaborators

    • Daegu Catholic University Medical Center
    • Research Institute of Medical Science, Daegu Catholic University

    Investigators

    • Principal Investigator: Jong Hae Kim, MD, Daegu Catholic University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    JongHae Kim, Associate Professor, Daegu Catholic University Medical Center
    ClinicalTrials.gov Identifier:
    NCT03514342
    Other Study ID Numbers:
    • 2018-02
    First Posted:
    May 2, 2018
    Last Update Posted:
    Jun 18, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by JongHae Kim, Associate Professor, Daegu Catholic University Medical Center
    Heart rate variability
    Mesopic pupil size
    Additional relevant MeSH terms:
    Horner Syndrome
    Syndrome
    Ropivacaine

    Study Results

    No Results Posted as of Jun 18, 2021