Interscalene Brachial Plexus BlockNCT05944497
Changes in Pulse Wave Transit Time and Its Variability After Placement of Interscalene Brachial Plexus Block
An observational study of Interscalene Brachial Plexus Block, run by JongHae Kim at 1 site in South Korea.
Trial summary
Pulse wave transit time (PWTT) increases due to decreased arterial vascular tone resulting from sympathetic blockade caused by regional anesthesia. Its oscillation (PWTT variability) also contains information on the interaction between autonomic nervous system and the cardiovascular system. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Interscalene Brachial Plexus Block
- What is being tested?
- Interscalene brachial plexus block
- Type of treatment
- Surgery or procedure
- How many people
- 59 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Jul 2023to 7 Jan 2024
- 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 university medical center
Who may be able to join
- American Society of Anesthesiologists status of 1
- Scheduled to receive interscalene brachial plexus block for arthroscopic shoulder surgery
Who cannot join
- Coagulopathy
- Infection of the skin area for interscalene brachial plexus block
- Peripheral neuropathy or neurologic sequelae in the upper limb ipsilateral to the surgery
- Allergy to local anesthetics or a history of allergic shock
- Contralateral vocal cord palsy, hemidiaphragmatic paresis/paralysis or pneumo/hemo thorax
- Arrhythmias
Show all 13Show fewer
- Cardiac conduction abnormalities
- A history of medication affecting cardiac conduction
- Ischemic heart disease
- Hypertension
- Diabetes mellitus
- Thyroid disfunction
- Other medical conditions affecting autonomic nervous activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Pulse Wave Transit Time and Its Variability Measured From the Ipsilateral First Finger After Placement of Interscalene Brachial Plexus Block
Pulse wave transit time (PWTT) increases due to decreased arterial vascular tone resulting from sympathetic blockade caused by regional anesthesia. Its oscillation (PWTT variability) also contains information on the interaction between autonomic nervous system and the cardiovascular system. The changes in PWTT and its variability have not been investigated in patients receiving interscalene brachial plexus block (ISBPB). It was hypothesized that ISBPB increases PWTT and reduces low frequency power of PWTT variability.
- Conditions
- Interscalene Brachial Plexus Block
- Being tested
- Interscalene brachial plexus block
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
Using a linear ultrasound transducer connected to an ultrasound machine, the compactly arranged brachial plexus is visualized lateral to the pulsating subclavian artery. The transducer is moved cephalad to visualize the 5th to 8th cervical (C5 to C8) nerve roots located between the anterior and middle scalene muscles. Using an in-plane technique, a block needle is inserted close to a nerve root in a lateral-to-medial direction. The needle is moved to place 0.75% ropivacaine around each nerve root. The C8 nerve root is blocked first, and the C5 nerve root is blocked last. After blocking the four cervical nerve roots, ropivacaine is placed in the intermuscular plane between the sternocleidomastoid and scalene muscles to block the supraclavicular nerves. A total of 26 ml of 0.75% ropivacaine is used for the interscalene brachial plexus block (6 ml per nerve root and 2 ml for the supraclavicular nerves).
| Study group | Role | What they receive |
|---|---|---|
| ISBPB group | Interscalene brachial plexus block involving the C5 to C8 nerve roots Receives: Procedure: Interscalene brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natural-log-transformed low frequency power of pulse wave transit time variability
Calculated by integrating the power spectra of pulse wave transit time variability between 0.04 and 0.15 Hz.
Measured: Between 15 and 20 minutes after block needle insertion
Secondary outcomes (13)
Natural-log-transformed low frequency power of pulse wave transit time variability
Calculated by integrating the power spectra of pulse wave transit time variability between 0.04 and 0.15 Hz.
Measured: During 5 minutes before the end of the acclimatization period
Natural-log-transformed low frequency power of pulse wave transit time variability
Calculated by integrating the power spectra of pulse wave transit time variability between 0.04 and 0.15 Hz.
Measured: Between 5 and 10 minutes after block needle insertion
Natural-log-transformed high frequency power of pulse wave transit time variability
Calculated by integrating the power spectra of pulse wave transit time variability between 0.15 and 0.4 Hz.
Measured: During 5 minutes before the end of the acclimatization period
Natural-log-transformed high frequency power of pulse wave transit time variability
Calculated by integrating the power spectra of pulse wave transit time variability between 0.15 and 0.4 Hz.
Measured: Between 5 and 10 minutes after block needle insertion
Natural-log-transformed high frequency power of pulse wave transit time variability
Calculated by integrating the power spectra of pulse wave transit time variability between 0.15 and 0.4 Hz.
Measured: Between 15 and 20 minutes after block needle insertion
Pulse wave transit time
Time difference in milliseconds between the R peak of the electrocardiographic waveform and the peak of the 2nd-derivative photoplethysmographic waveform.
Measured: During 5 minutes before the end of the acclimatization period
Pulse wave transit time
Time difference in milliseconds between the R peak of the electrocardiographic waveform and the peak of the 2nd-derivative photoplethysmographic waveform.
Measured: Between 5 and 10 minutes after block needle insertion
Pulse wave transit time
Time difference in milliseconds between the R peak of the electrocardiographic waveform and the peak of the 2nd-derivative photoplethysmographic waveform.
Measured: Between 15 and 20 minutes after block needle insertion
Sensory blockade
Assessed by grading the coldness with a 3-level scale consisting of 0 (no cold sensation), 1 (reduced cold sensation), and 2 (normal cold sensation) after applying an alcohol swab to the upper limb dermatomal areas innervated by the C5 to T1 nerve roots.
Measured: 20 minutes after block needle insertion
Motor blockade
The muscle contraction power is rated as 0 (complete block), 1 (partial block), and 2 (no block) for shoulder abduction (axillary nerve), elbow flexion (musculocutaneous nerve), forearm supination (radial nerve), forearm pronation (median nerve), wrist extension (radial nerve), wrist flexion (median nerve), finger abduction (ulnar nerve), thumb abduction (radial nerve), thumb adduction (ulnar nerve), and thumb opposition (median nerve).
Measured: 20 minutes after block needle insertion
Bilateral pupil diameters
Measured using a portable automated monocular infrared pupillometer (PLR-3000, NeurOptics Inc., Irvine, CA, the United States) at 30 Hz for 2 seconds.
Measured: Within 1 minute after acclimatization
Bilateral pupil diameters
Measured using a portable automated monocular infrared pupillometer (PLR-3000, NeurOptics Inc., Irvine, CA, the United States) at 30 Hz for 2 seconds.
Measured: 20 minutes after block needle insertion
Incidence of side effects related to interscalene brachial plexus block
Horner's syndrome, subjective dyspnea, and hoarseness
Measured: 20 minutes after block needle insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start31 Jul 2023
- Primary completion7 Jan 2024
- Study completion7 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interscalene 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- JongHae Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, JongHae Kim, Daegu Catholic University Medical Center
- Investigators
- Jonghae Kim, M.D., Principal investigator, Daegu Catholic University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944497
- Sponsor's protocol ID
- 2023-01
- Status last verified
- Jan 2024
- First submitted
- 28 Jun 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be available from the primary investigator on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Pulse Wave Transit Time and Its Variability Measured From the Ipsilateral First Finger After Placement of Interscalene Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT05944497
- Acronym / sponsor ID
- 2023-01
- Conditions
- Interscalene Brachial Plexus Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- JongHae KimUniversity, hospital or other
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 7 Jan 2024 (actual)
- Study completion
- 7 Jan 2024 (actual)
- First posted
- 13 Jul 2023 (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.
Pulse wave transit time (PWTT) increases due to decreased arterial vascular tone resulting from sympathetic blockade caused by regional anesthesia. Its oscillation (PWTT variability) also contains information on the interaction between autonomic nervous system and the cardiovascular system. The changes in PWTT and its variability have not been investigated in patients receiving interscalene brachial plexus block (ISBPB). It was hypothesized that ISBPB increases PWTT and reduces low frequency power of PWTT variability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ISBPB group | – | Procedure: Interscalene brachial plexus blockInterscalene brachial plexus block involving the C5 to C8 nerve roots |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Tertiary university medical center
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists status of 1
- Scheduled to receive interscalene brachial plexus block for arthroscopic shoulder surgery
Key exclusion criteria (13 listed)
- Coagulopathy
- Infection of the skin area for interscalene brachial plexus block
- Peripheral neuropathy or neurologic sequelae in the upper limb ipsilateral to the surgery
- Allergy to local anesthetics or a history of allergic shock
- Contralateral vocal cord palsy, hemidiaphragmatic paresis/paralysis or pneumo/hemo thorax
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 blockUsing a linear ultrasound transducer connected to an ultrasound machine, the compactly arranged brachial plexus is visualized lateral to the pulsating subclavian artery. The transducer is moved cephalad to visualize the 5th to 8th cervical (C5 to C8) nerve roots located between the anterior and middle scalene muscles. Using an in-plane technique, a block needle is inserted close to a nerve root in a lateral-to-medial direction. The needle is moved to place 0.75% ropivacaine around each nerve root. The C8 nerve root is blocked first, and the C5 nerve root is blocked last. After blocking the four cervical nerve roots, ropivacaine is placed in the intermuscular plane between the sternocleidomastoid and scalene muscles to block the supraclavicular nerves. A total of 26 ml of 0.75% ropivacaine is used for the interscalene brachial plexus block (6 ml per nerve root and 2 ml for the supraclavicular nerves). | Procedure or surgery | ISBPB group |
Primary outcome
Natural-log-transformed low frequency power of pulse wave transit time variability
Time frame: Between 15 and 20 minutes after block needle insertion
Calculated by integrating the power spectra of pulse wave transit time variability between 0.04 and 0.15 Hz.
13 secondary outcomes
Natural-log-transformed low frequency power of pulse wave transit time variability
Time frame: During 5 minutes before the end of the acclimatization period
Natural-log-transformed low frequency power of pulse wave transit time variability
Time frame: Between 5 and 10 minutes after block needle insertion
Natural-log-transformed high frequency power of pulse wave transit time variability
Time frame: During 5 minutes before the end of the acclimatization period
Natural-log-transformed high frequency power of pulse wave transit time variability
Time frame: Between 5 and 10 minutes after block needle insertion
Natural-log-transformed high frequency power of pulse wave transit time variability
Time frame: Between 15 and 20 minutes after block needle insertion
Pulse wave transit time
Time frame: During 5 minutes before the end of the acclimatization period
Pulse wave transit time
Time frame: Between 5 and 10 minutes after block needle insertion
Pulse wave transit time
Time frame: Between 15 and 20 minutes after block needle insertion
Sensory blockade
Time frame: 20 minutes after block needle insertion
Motor blockade
Time frame: 20 minutes after block needle insertion
Bilateral pupil diameters
Time frame: Within 1 minute after acclimatization
Bilateral pupil diameters
Time frame: 20 minutes after block needle insertion
Incidence of side effects related to interscalene brachial plexus block
Time frame: 20 minutes after block needle insertion
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 23 Jan 2024.
- Individual participant dataSharing planned: No. IPD will be available from the primary investigator on reasonable request.
Related trials for Interscalene Brachial Plexus Block
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Combined Suprascapular and PECS I Blocks Versus Interscalene Block for Shoulder Arthroscopy
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RecruitingPhase 4
Intravenous Dexamethasone With Single-Shot Versus Continuous Brachial Plexus Block for Rebound Pain After Shoulder Surgery
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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.
Jonghae Kim, M.D. 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 Interscalene Brachial Plexus Block, run by JongHae Kim 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 13 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 23 Jan 2024. 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?
Natural-log-transformed low frequency power of pulse wave transit time variability (time frame: Between 15 and 20 minutes after block needle insertion). 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 23 Jan 2024.