The Effects of Horner's Syndrome Developing After Interscalene Brachial Plexus Block on Autonomic Nervous Activity
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03514342 |
Recruitment Status :
Completed
First Posted : May 2, 2018
Last Update Posted : July 2, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Brachial Plexus Block Horner Syndrome Autonomic Imbalance | Procedure: Interscalene brachial plexus block Drug: 0.75% ropivacaine |
Study Type : | Observational |
Actual Enrollment : | 49 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | The Effects of Difference in Pupil Size Between Bilateral Eyes on Cardiac Sympathetic Nervous Activity Following Interscalene Brachial Plexus Block |
Actual Study Start Date : | June 18, 2018 |
Actual Primary Completion Date : | July 1, 2019 |
Actual Study Completion Date : | July 1, 2019 |

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 Name: Naropin |
- Post-anesthetic sympathetic nervous activity [ Time Frame: 30 minutes after 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 25 and 30 minutes after interscalene brachial plexus block
- Post-anesthetic difference in pupil diameter between bilateral eyes [ Time Frame: 30 minutes after interscalene brachial plexus block ]Ipsilateral pupil diameter subtracted from contralateral pupil diameter, which are measured under a scotopic light condition 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
- Post-anesthetic sympathovagal balance [ Time Frame: Between 25 and 30 minutes after interscalene brachial plexus block ]Natural-log transformed low-to-high frequency power ratio of heart rate variability 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
- Pre-anesthetic sympathetic nervous activity [ Time Frame: During 5 minutes before interscalene brachial plexus block ]Natural-log transformed low frequency power of heart rate variability during 5 minutes before interscalene brachial plexus block
- Pre-anesthetic parasympathetic nervous activity [ Time Frame: During 5 minutes before interscalene brachial plexus block ]Natural-log transformed high frequency power of heart rate variability during 5 minutes before interscalene brachial plexus block
- Pre-anesthetic sympathovagal balance [ Time Frame: During 5 minutes before interscalene brachial plexus block ]Natural-log transformed low-to-high frequency power ratio of heart rate variability during 5 minutes before interscalene brachial plexus block
- Pre-anesthetic overall variability of autonomic nervous system [ Time Frame: During 5 minutes before interscalene brachial plexus block ]Natural-log transformed total power of heart rate variability during 5 minutes before interscalene brachial plexus block
- Pre-anesthetic difference in pupil diameter between bilateral eyes [ Time Frame: 30 seconds before interscalene brachial plexus block ]Ipsilateral pupil diameter subtracted from contralateral pupil diameter, which are measured under a scotopic light condition 30 seconds before interscalene brachial plexus block
- 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
- 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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514342
Korea, Republic of | |
Daegu Catholic University Medical Center | |
Daegu, Korea, Republic of, 42472 |
Principal Investigator: | Jong Hae Kim, MD | Daegu Catholic University Medical Center |
Responsible Party: | JongHae Kim, Associate Professor, Daegu Catholic University Medical Center |
ClinicalTrials.gov Identifier: | NCT03514342 |
Other Study ID Numbers: |
2018-02 |
First Posted: | May 2, 2018 Key Record Dates |
Last Update Posted: | July 2, 2019 |
Last Verified: | July 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Heart rate variability Scotopic pupil size |
Horner Syndrome Syndrome Disease Pathologic Processes Autonomic Nervous System Diseases Nervous System Diseases Miosis Pupil Disorders Neurologic Manifestations |
Eye Diseases Ropivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |