Changes in Pulse Wave Transit Time and Its Variability After Placement of Interscalene Brachial Plexus Block

January 22, 2024 updated by: JongHae Kim

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of, 42472
        • Daegu Catholic University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Tertiary university medical center

Description

Inclusion Criteria:

  • American Society of Anesthesiologists status of 1
  • Scheduled to receive interscalene brachial plexus block for arthroscopic shoulder surgery

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ISBPB group
Interscalene brachial plexus block involving the C5 to C8 nerve roots
Procedure: Interscalene brachial plexus block
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Between 15 and 20 minutes after block needle insertion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Natural-log-transformed low frequency power of pulse wave transit time variability
Time Frame: During 5 minutes before the end of the acclimatization period
Calculated by integrating the power spectra of pulse wave transit time variability between 0.04 and 0.15 Hz.
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
Calculated by integrating the power spectra of pulse wave transit time variability between 0.04 and 0.15 Hz.
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
Calculated by integrating the power spectra of pulse wave transit time variability between 0.15 and 0.4 Hz.
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
Calculated by integrating the power spectra of pulse wave transit time variability between 0.15 and 0.4 Hz.
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
Calculated by integrating the power spectra of pulse wave transit time variability between 0.15 and 0.4 Hz.
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
Time difference in milliseconds between the R peak of the electrocardiographic waveform and the peak of the 2nd-derivative photoplethysmographic waveform.
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
Time difference in milliseconds between the R peak of the electrocardiographic waveform and the peak of the 2nd-derivative photoplethysmographic waveform.
Between 5 and 10 minutes after block needle insertion
Pulse wave transit time
Time Frame: Between 15 and 20 minutes after block needle insertion
Time difference in milliseconds between the R peak of the electrocardiographic waveform and the peak of the 2nd-derivative photoplethysmographic waveform.
Between 15 and 20 minutes after block needle insertion
Sensory blockade
Time Frame: 20 minutes after block needle insertion
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.
20 minutes after block needle insertion
Motor blockade
Time Frame: 20 minutes after block needle insertion
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).
20 minutes after block needle insertion
Bilateral pupil diameters
Time Frame: Within 1 minute after acclimatization
Measured using a portable automated monocular infrared pupillometer (PLR-3000, NeurOptics Inc., Irvine, CA, the United States) at 30 Hz for 2 seconds.
Within 1 minute after acclimatization
Bilateral pupil diameters
Time Frame: 20 minutes after block needle insertion
Measured using a portable automated monocular infrared pupillometer (PLR-3000, NeurOptics Inc., Irvine, CA, the United States) at 30 Hz for 2 seconds.
20 minutes after block needle insertion
Incidence of side effects related to interscalene brachial plexus block
Time Frame: 20 minutes after block needle insertion
Horner's syndrome, subjective dyspnea, and hoarseness
20 minutes after block needle insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
JongHae Kim

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonghae Kim, M.D., Daegu Catholic University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 31, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 7, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 7, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will be available from the primary investigator on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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