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

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ClinicalTrials.gov Identifier: NCT03514342
Recruitment Status : Completed
First Posted : May 2, 2018
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
Research Institute of Medical Science, Daegu Catholic University
Information provided by (Responsible Party):
JongHae Kim, Daegu Catholic University Medical Center

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.

Condition or disease Intervention/treatment
Brachial Plexus Block Horner Syndrome Autonomic Imbalance 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.

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Study Type : Observational
Actual Enrollment : 49 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 : June 18, 2018
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort 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 Name: Naropin




Primary Outcome Measures :
  1. Post-anesthetic sympathetic nervous activity [ Time Frame: 30 minutes after 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 25 and 30 minutes after interscalene brachial plexus block


Secondary Outcome Measures :
  1. Post-anesthetic difference in pupil diameter between bilateral eyes [ Time Frame: 30 minutes after interscalene brachial plexus block ]
    Ipsilateral pupil diameter subtracted from contralateral pupil diameter, which are measured under a scotopic light condition 30 minutes after interscalene brachial plexus block

  2. 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

  3. Post-anesthetic sympathovagal balance [ Time Frame: Between 25 and 30 minutes after interscalene brachial plexus block ]
    Natural-log transformed low-to-high frequency power ratio of heart rate variability between 25 and 30 minutes after interscalene brachial plexus block

  4. 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

  5. Pre-anesthetic sympathetic nervous activity [ Time Frame: During 5 minutes before interscalene brachial plexus block ]
    Natural-log transformed low frequency power of heart rate variability during 5 minutes before interscalene brachial plexus block

  6. Pre-anesthetic parasympathetic nervous activity [ Time Frame: During 5 minutes before interscalene brachial plexus block ]
    Natural-log transformed high frequency power of heart rate variability during 5 minutes before interscalene brachial plexus block

  7. Pre-anesthetic sympathovagal balance [ Time Frame: During 5 minutes before interscalene brachial plexus block ]
    Natural-log transformed low-to-high frequency power ratio of heart rate variability during 5 minutes before interscalene brachial plexus block

  8. Pre-anesthetic overall variability of autonomic nervous system [ Time Frame: During 5 minutes before interscalene brachial plexus block ]
    Natural-log transformed total power of heart rate variability during 5 minutes before interscalene brachial plexus block

  9. Pre-anesthetic difference in pupil diameter between bilateral eyes [ Time Frame: 30 seconds before interscalene brachial plexus block ]
    Ipsilateral pupil diameter subtracted from contralateral pupil diameter, which are measured under a scotopic light condition 30 seconds before interscalene brachial plexus block

  10. 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

  11. 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)



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Tertiary hospital
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514342


Locations
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Korea, Republic of
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
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Principal Investigator: Jong Hae Kim, MD Daegu Catholic University Medical Center

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Responsible Party: JongHae Kim, Associate Professor, Daegu Catholic University Medical Center
ClinicalTrials.gov Identifier: NCT03514342     History of Changes
Other Study ID Numbers: 2018-02
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by JongHae Kim, Daegu Catholic University Medical Center:
Heart rate variability
Scotopic pupil size
Additional relevant MeSH terms:
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Horner Syndrome
Syndrome
Disease
Pathologic Processes
Autonomic Nervous System Diseases
Nervous System Diseases
Miosis
Pupil Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents