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

June 15, 2021 updated by: JongHae Kim, Daegu Catholic University Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Post-sitting sympathetic nervous activity
Time Frame: 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
15 minutes after the sitting position following interscalene brachial plexus block

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Post-sitting ipsilateral pupil diameter
Time Frame: 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
15 minutes after the sitting position following interscalene brachial plexus block
Post-sitting contralateral pupil diameter
Time Frame: 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
15 minutes after the sitting position following interscalene brachial plexus block
Post-anesthetic ipsilateral pupil diameter
Time Frame: 30 minutes after interscalene brachial plexus block
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
Time Frame: 30 minutes after interscalene brachial plexus block
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
Time Frame: 15 minutes after baseline acclimation
Ipsilateral pupil diameter measured under a mesopic condition 15 minutes after baseline acclimation
15 minutes after baseline acclimation
Pre-anesthetic contralateral pupil diameter
Time Frame: 15 minutes after baseline acclimation
Contralateral pupil diameter measured under a mesopic condition 15 minutes after baseline acclimation
15 minutes after baseline acclimation
Post-sitting parasympathetic nervous activity
Time Frame: 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
15 minutes after the sitting position following interscalene brachial plexus block
Post-sitting sympathovagal balance
Time Frame: 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
15 minutes after the sitting position following interscalene brachial plexus block
Post-sitting overall variability of autonomic nervous system
Time Frame: 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
15 minutes after the sitting position following interscalene brachial plexus block
Post-anesthetic sympathetic nervous activity
Time Frame: 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
Between 25 and 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
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
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
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
Between 25 and 30 minutes after interscalene brachial plexus block
Pre-anesthetic sympathetic nervous activity
Time Frame: 15 minutes after baseline acclimiation
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
Time Frame: 15 minutes after baseline acclimiation
Natural-log transformed high frequency power of heart rate variability 15 minutes after baseline acclimation
15 minutes after baseline acclimiation
Pre-anesthetic sympathovagal balance
Time Frame: 15 minutes after baseline acclimiation
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
Time Frame: 15 minutes after baseline acclimation
Natural-log transformed total power of heart rate variability 15 minutes after baseline acclimation
15 minutes after baseline acclimation
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
30 minutes after interscalene brachial plexus block
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)
30 minutes after interscalene brachial plexus block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daegu Catholic University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Research Institute of Medical Science, Daegu Catholic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jong Hae Kim, MD, Daegu Catholic University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 18, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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