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

NCT05944497 | Completed

• 1 other identifier: 2023-01
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Between 15 and 20 minutes after block needle insertion

Secondary Outcomes (13)

• Natural-log-transformed low frequency power of pulse wave transit time variability

  During 5 minutes before the end of the acclimatization period

• Natural-log-transformed low frequency power of pulse wave transit time variability

  Between 5 and 10 minutes after block needle insertion

• Natural-log-transformed high frequency power of pulse wave transit time variability

  During 5 minutes before the end of the acclimatization period

• Natural-log-transformed high frequency power of pulse wave transit time variability

  Between 5 and 10 minutes after block needle insertion

• Natural-log-transformed high frequency power of pulse wave transit time variability

  Between 15 and 20 minutes after block needle insertion

Study Arms (1)

ISBPB group

Interscalene brachial plexus block involving the C5 to C8 nerve roots

Procedure: Interscalene brachial plexus block

Interventions

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).

ISBPB group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Tertiary university medical center

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• JongHae Kim: lead

Study Sites (1)

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

Location

Study Officials

• Jonghae Kim, M.D.

  Daegu Catholic University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 13, 2023
• Study Start: July 31, 2023
• Primary Completion: January 7, 2024
• Study Completion: January 7, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)