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Completed

NCT Number: NCT05944497

Changes in Pulse Wave Transit Time and Its Variability 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.

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Key information

Conditions

Interscalene Brachial Plexus Block

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interscalene brachial plexus block

Procedure

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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).

  11. 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.

  12. 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.

  13. 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

Sponsors and collaborators

Lead sponsor

JongHae Kim

Other

Registry information

Official study title

Changes in Pulse Wave Transit Time and Its Variability Measured From the Ipsilateral First Finger After Placement of Interscalene Brachial Plexus Block

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 13, 2023
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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