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

Brachial Plexus Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03514342
• Other study ID #: 2018-02
• Status: Completed
• Start date: June 18, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: June 2021
• Source: Daegu Catholic University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Autonomic Imbalance
• Brachial Plexus Block
• Horner Syndrome
• Syndrome

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

Locations

Country	Name	City	State
Korea, Republic of	Daegu Catholic University Medical Center	Daegu

Sponsors (2)

Lead Sponsor	Collaborator
Daegu Catholic University Medical Center	Research Institute of Medical Science, Daegu Catholic University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Pre-anesthetic ipsilateral pupil diameter	Ipsilateral pupil diameter measured under a mesopic condition 15 minutes after baseline acclimation	15 minutes after baseline acclimation
Secondary	Pre-anesthetic contralateral pupil diameter	Contralateral pupil diameter measured under a mesopic condition 15 minutes after baseline acclimation	15 minutes after baseline acclimation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Pre-anesthetic sympathovagal balance	Low-to-high frequency power ratio of heart rate variability 15 minutes after baseline acclimation	15 minutes after baseline acclimiation
Secondary	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
Secondary	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
Secondary	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