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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

Tracking Information
First Submitted Date April 19, 2018
First Posted Date May 2, 2018
Last Update Posted Date July 2, 2019
Actual Study Start Date June 18, 2018
Actual Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 1, 2018)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 1, 2018)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Effects of Horner's Syndrome Developing After Interscalene Brachial Plexus Block on Autonomic Nervous Activity
Official Title The Effects of Difference in Pupil Size Between Bilateral Eyes on Cardiac Sympathetic Nervous Activity Following Interscalene Brachial Plexus Block
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Tertiary hospital
Condition
  • Brachial Plexus Block
  • Horner Syndrome
  • Autonomic Imbalance
Intervention
  • 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
Study Groups/Cohorts Interscalene brachial plexus block
Ultrasound-guided interscalene brachial plexus block with 25 ml to 30 ml of 0.75% ropivacaine
Interventions:
  • Procedure: Interscalene brachial plexus block
  • Drug: 0.75% ropivacaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 1, 2018)
49
Original Estimated Enrollment Same as current
Actual Study Completion Date July 1, 2019
Actual Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03514342
Other Study ID Numbers 2018-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party JongHae Kim, Daegu Catholic University Medical Center
Study Sponsor Daegu Catholic University Medical Center
Collaborators Research Institute of Medical Science, Daegu Catholic University
Investigators
Principal Investigator: Jong Hae Kim, MD Daegu Catholic University Medical Center
PRS Account Daegu Catholic University Medical Center
Verification Date July 2019