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

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

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.

Study Overview

• Status: Completed
• Conditions: Brachial Plexus Block; Horner Syndrome; Autonomic Imbalance
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 42472
    • Daegu Catholic University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Tertiary hospital

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: Naropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-sitting sympathetic nervous activity	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	15 minutes after the sitting position following interscalene brachial plexus block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-sitting ipsilateral pupil diameter	Ipsilateral pupil diameter measured under a mesopic condition 15 minutes after the sitting position following interscalene brachial plexus block	15 minutes after the sitting position following interscalene brachial plexus block
Post-sitting contralateral pupil diameter	Contralateral pupil diameter measured under a mesopic condition 15 minutes after the sitting position following interscalene brachial plexus block	15 minutes after the sitting position following interscalene brachial plexus block
Post-anesthetic ipsilateral pupil diameter	Ipsilateral pupil diameter measured under a mesopic condition 30 minutes after interscalene brachial plexus block	30 minutes after interscalene brachial plexus block
Post-anesthetic contralateral pupil diameter	Contralateral pupil diameter measured under a mesopic condition 30 minutes after interscalene brachial plexus block	30 minutes after interscalene brachial plexus block
Pre-anesthetic ipsilateral pupil diameter	Ipsilateral pupil diameter measured under a mesopic condition 15 minutes after baseline acclimation	15 minutes after baseline acclimation
Pre-anesthetic contralateral pupil diameter	Contralateral pupil diameter measured under a mesopic condition 15 minutes after baseline acclimation	15 minutes after baseline acclimation
Post-sitting parasympathetic nervous activity	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	15 minutes after the sitting position following interscalene brachial plexus block
Post-sitting sympathovagal balance	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	15 minutes after the sitting position following interscalene brachial plexus block
Post-sitting overall variability of autonomic nervous system	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	15 minutes after the sitting position following interscalene brachial plexus block
Post-anesthetic sympathetic nervous activity	Natural-log transformed low frequency power of heart rate variability between 25 and 30 minutes after interscalene brachial plexus block	Between 25 and 30 minutes after interscalene brachial plexus block
Post-anesthetic parasympathetic nervous activity	Natural-log transformed high frequency power of heart rate variability between 25 and 30 minutes after interscalene brachial plexus block	Between 25 and 30 minutes after interscalene brachial plexus block
Post-anesthetic sympathovagal balance	Low-to-high frequency power ratio of heart rate variability between 25 and 30 minutes after interscalene brachial plexus block	Between 25 and 30 minutes after interscalene brachial plexus block
Post-anesthetic overall variability of autonomic nervous system	Natural-log transformed total power of heart rate variability between 25 and 30 minutes after interscalene brachial plexus block	Between 25 and 30 minutes after interscalene brachial plexus block
Pre-anesthetic sympathetic nervous activity	Natural-log transformed low frequency power of heart rate variability 15 minutes after baseline acclimation	15 minutes after baseline acclimiation
Pre-anesthetic parasympathetic nervous activity	Natural-log transformed high frequency power of heart rate variability 15 minutes after baseline acclimation	15 minutes after baseline acclimiation
Pre-anesthetic sympathovagal balance	Low-to-high frequency power ratio of heart rate variability 15 minutes after baseline acclimation	15 minutes after baseline acclimiation
Pre-anesthetic overall variability of autonomic nervous system	Natural-log transformed total power of heart rate variability 15 minutes after baseline acclimation	15 minutes after baseline acclimation
Sensory blockade	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	30 minutes after interscalene brachial plexus block
Motor blockade	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)	30 minutes after interscalene brachial plexus block

Collaborators and Investigators

• 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

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2018
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: May 1, 2018
• First Posted (Actual): May 2, 2018

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Heart rate variability; Mesopic pupil size
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Disease; Autonomic Nervous System Diseases; Miosis; Pupil Disorders; Syndrome; Horner Syndrome; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 2018-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No