NCT03514342

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 2, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 18, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

April 19, 2018

Last Update Submit

June 15, 2021

Conditions

Brachial Plexus BlockHorner SyndromeAutonomic Imbalance

Keywords

Heart rate variabilityMesopic pupil size

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (19)

  • Post-sitting ipsilateral pupil diameter

    15 minutes after the sitting position following interscalene brachial plexus block

  • Post-sitting contralateral pupil diameter

    15 minutes after the sitting position following interscalene brachial plexus block

  • Post-anesthetic ipsilateral pupil diameter

    30 minutes after interscalene brachial plexus block

  • Post-anesthetic contralateral pupil diameter

    30 minutes after interscalene brachial plexus block

  • Pre-anesthetic ipsilateral pupil diameter

    15 minutes after baseline acclimation

  • +14 more secondary outcomes

Study Arms (1)

Interscalene brachial plexus block

Ultrasound-guided interscalene brachial plexus block with 25 ml to 30 ml of 0.75% ropivacaine

Procedure: Interscalene brachial plexus blockDrug: 0.75% ropivacaine

Interventions

Interscalene brachial plexus blockPROCEDURE

Under ultrasound guidance, the 5th to 7th cervical nerve roots are identified between anterior and middle scalene muscles and subsequently blocked.

Interscalene brachial plexus block
0.75% ropivacaineDRUG

Placement of 25 to 30 ml of 0.75% ropivacaine around the 5th to 7th cervical nerve roots

Also known as: Naropin
Interscalene brachial plexus block

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Tertiary hospital

You may qualify if:

  • American Society of Anesthesiologists physical status 1
  • Arthroscopic shoulder surgery under interscalene brachial plexus block

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

Location

MeSH Terms

Conditions

Horner Syndrome

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesCavernous Sinus SyndromesBrain DiseasesCentral Nervous System DiseasesMiosisPupil DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Jong Hae Kim, MD

    Daegu Catholic University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 19, 2018

First Posted

May 2, 2018

Study Start

June 18, 2018

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

June 18, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)