Brachial Plexus BlockNCT03514342
The Effects of Horner's Syndrome Developing After Interscalene Brachial Plexus Block on Autonomic Nervous Activity
An observational study of Brachial Plexus Block and Horner Syndrome, run by Daegu Catholic University Medical Center at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Brachial Plexus Block, Horner Syndrome, Autonomic Imbalance
- What is being tested?
- Interscalene brachial plexus block and 0.75% ropivacaine
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Jun 2018to 1 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Tertiary hospital
Who may be able to join
- American Society of Anesthesiologists physical status 1
- Arthroscopic shoulder surgery under interscalene brachial plexus block
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Brachial Plexus Block, Horner Syndrome, Autonomic Imbalance
- Being tested
- Interscalene brachial plexus block, 0.75% ropivacaine
- Keywords
- Heart rate variability, Mesopic pupil size
- Medical subject headings
- Horner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene brachial plexus blockProcedure or surgery
Under ultrasound guidance, the 5th to 7th cervical nerve roots are identified between anterior and middle scalene muscles and subsequently blocked.
0.75% ropivacaineDrug
Also called Naropin
Placement of 25 to 30 ml of 0.75% ropivacaine around the 5th to 7th cervical nerve roots
| Study group | Role | What they receive |
|---|---|---|
| Interscalene brachial plexus block | Ultrasound-guided interscalene brachial plexus block with 25 ml to 30 ml of 0.75% ropivacaine Receives: Procedure: Interscalene brachial plexus block; Drug: 0.75% ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 minutes after the sitting position following interscalene brachial plexus block
Secondary outcomes (19)
Post-sitting ipsilateral pupil diameter
Ipsilateral pupil diameter measured under a mesopic condition 15 minutes after the sitting position following interscalene brachial plexus block
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 15 minutes after baseline acclimation
Pre-anesthetic contralateral pupil diameter
Contralateral pupil diameter measured under a mesopic condition 15 minutes after baseline acclimation
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 15 minutes after baseline acclimiation
Pre-anesthetic sympathovagal balance
Low-to-high frequency power ratio of heart rate variability 15 minutes after baseline acclimation
Measured: 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
Measured: 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
Measured: 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)
Measured: 30 minutes after interscalene brachial plexus block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start18 Jun 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brachial Plexus BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daegu Catholic University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Research Institute of Medical Science, Daegu Catholic University
- Responsible party
- Principal investigator, JongHae Kim, Daegu Catholic University Medical Center
- Investigators
- Jong Hae Kim, MD, Principal investigator, Daegu Catholic University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514342
- Sponsor's protocol ID
- 2018-02
- Status last verified
- Jun 2021
- First submitted
- 19 Apr 2018
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Difference in Pupil Size Between Bilateral Eyes on Cardiac Sympathetic Nervous Activity Following Interscalene Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT03514342
- Acronym / sponsor ID
- 2018-02
- Conditions
- Brachial Plexus Block, Horner Syndrome, Autonomic Imbalance
- Keywords
- Heart rate variability, Mesopic pupil size
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Daegu Catholic University Medical CenterUniversity, hospital or other
- Collaborators
- Research Institute of Medical Science, Daegu Catholic University
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 2 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interscalene brachial plexus block | – | Procedure: Interscalene brachial plexus block, Drug: 0.75% ropivacaineUltrasound-guided interscalene brachial plexus block with 25 ml to 30 ml of 0.75% ropivacaine |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Tertiary hospital
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status 1
- Arthroscopic shoulder surgery under interscalene brachial plexus block
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interscalene brachial plexus blockUnder ultrasound guidance, the 5th to 7th cervical nerve roots are identified between anterior and middle scalene muscles and subsequently blocked. | Procedure or surgery | Interscalene brachial plexus block |
| 0.75% ropivacaineAlso: NaropinPlacement of 25 to 30 ml of 0.75% ropivacaine around the 5th to 7th cervical nerve roots | Drug | Interscalene brachial plexus block |
Primary outcome
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
19 secondary outcomes
Post-sitting ipsilateral pupil diameter
Time frame: 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
Post-anesthetic ipsilateral pupil diameter
Time frame: 30 minutes after interscalene brachial plexus block
Post-anesthetic contralateral pupil diameter
Time frame: 30 minutes after interscalene brachial plexus block
Pre-anesthetic ipsilateral pupil diameter
Time frame: 15 minutes after baseline acclimation
Pre-anesthetic contralateral pupil diameter
Time frame: 15 minutes after baseline acclimation
Post-sitting parasympathetic nervous activity
Time frame: 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
Post-sitting overall variability of autonomic nervous system
Time frame: 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
Post-anesthetic parasympathetic nervous activity
Time frame: 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
Post-anesthetic overall variability of autonomic nervous system
Time frame: Between 25 and 30 minutes after interscalene brachial plexus block
Pre-anesthetic sympathetic nervous activity
Time frame: 15 minutes after baseline acclimiation
Pre-anesthetic parasympathetic nervous activity
Time frame: 15 minutes after baseline acclimiation
Pre-anesthetic sympathovagal balance
Time frame: 15 minutes after baseline acclimiation
Pre-anesthetic overall variability of autonomic nervous system
Time frame: 15 minutes after baseline acclimation
Sensory blockade
Time frame: 30 minutes after interscalene brachial plexus block
Motor blockade
Time frame: 30 minutes after interscalene brachial plexus block
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: No
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Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Not yet recruiting
Perfusion Index in Monitoring Recovery From Brachial Plexus Block After Forearm Surgery
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RecruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong Hae Kim, MD principal investigator
Daegu Catholic University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brachial Plexus Block and Horner Syndrome, run by Daegu Catholic University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-sitting sympathetic nervous activity (time frame: 15 minutes after the sitting position following interscalene brachial plexus block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.