Clinical trial NCT03514342: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brachial Plexus Block
Horner Syndrome
Autonomic Imbalance
Keywords: Heart rate variability
Mesopic pupil size
Lead sponsor: Daegu Catholic University Medical Center
Sponsor class: OTHER
Collaborators: name: Research Institute of Medical Science, Daegu Catholic University
First posted: 2018-05-02
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary hospital

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.

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.

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

Primary outcomes:
measure: Post-sitting sympathetic nervous activity
timeFrame: 15 minutes after the sitting position following interscalene brachial plexus block
Secondary outcomes:
measure: Post-sitting ipsilateral pupil diameter
timeFrame: 15 minutes after the sitting position following interscalene brachial plexus block
measure: Post-sitting contralateral pupil diameter
timeFrame: 15 minutes after the sitting position following interscalene brachial plexus block
measure: Post-anesthetic ipsilateral pupil diameter
timeFrame: 30 minutes after interscalene brachial plexus block
measure: Post-anesthetic contralateral pupil diameter
timeFrame: 30 minutes after interscalene brachial plexus block
measure: Pre-anesthetic ipsilateral pupil diameter
timeFrame: 15 minutes after baseline acclimation
measure: Pre-anesthetic contralateral pupil diameter
timeFrame: 15 minutes after baseline acclimation
measure: Post-sitting parasympathetic nervous activity
timeFrame: 15 minutes after the sitting position following interscalene brachial plexus block
measure: Post-sitting sympathovagal balance
timeFrame: 15 minutes after the sitting position following interscalene brachial plexus block
measure: Post-sitting overall variability of autonomic nervous system
timeFrame: 15 minutes after the sitting position following interscalene brachial plexus block
measure: Post-anesthetic sympathetic nervous activity
timeFrame: Between 25 and 30 minutes after interscalene brachial plexus block
measure: Post-anesthetic parasympathetic nervous activity
timeFrame: Between 25 and 30 minutes after interscalene brachial plexus block
measure: Post-anesthetic sympathovagal balance
timeFrame: Between 25 and 30 minutes after interscalene brachial plexus block
measure: Post-anesthetic overall variability of autonomic nervous system
timeFrame: Between 25 and 30 minutes after interscalene brachial plexus block
measure: Pre-anesthetic sympathetic nervous activity
timeFrame: 15 minutes after baseline acclimiation
measure: Pre-anesthetic parasympathetic nervous activity
timeFrame: 15 minutes after baseline acclimiation
measure: Pre-anesthetic sympathovagal balance
timeFrame: 15 minutes after baseline acclimiation
measure: Pre-anesthetic overall variability of autonomic nervous system
timeFrame: 15 minutes after baseline acclimation
measure: Sensory blockade
timeFrame: 30 minutes after interscalene brachial plexus block
measure: Motor blockade
timeFrame: 30 minutes after interscalene brachial plexus block
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
Study officials:
affiliation: Daegu Catholic University Medical Center
name: Jong Hae Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: