Clinical trial NCT05944497: Changes in Pulse Wave Transit Time and Its Variability After Placement of Interscalene Brachial Plexus Block
Official title: Changes in Pulse Wave Transit Time and Its Variability Measured From the Ipsilateral First Finger After Placement of Interscalene Brachial Plexus Block
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interscalene Brachial Plexus Block
Lead sponsor: Daegu Catholic University Medical Center
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 59
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tertiary university medical center

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.


Eligibility criteria: 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

Primary outcomes:
measure: Natural-log-transformed low frequency power of pulse wave transit time variability
timeFrame: Between 15 and 20 minutes after block needle insertion
Secondary outcomes:
measure: Natural-log-transformed low frequency power of pulse wave transit time variability
timeFrame: During 5 minutes before the end of the acclimatization period
measure: Natural-log-transformed low frequency power of pulse wave transit time variability
timeFrame: Between 5 and 10 minutes after block needle insertion
measure: Natural-log-transformed high frequency power of pulse wave transit time variability
timeFrame: During 5 minutes before the end of the acclimatization period
measure: Natural-log-transformed high frequency power of pulse wave transit time variability
timeFrame: Between 5 and 10 minutes after block needle insertion
measure: Natural-log-transformed high frequency power of pulse wave transit time variability
timeFrame: Between 15 and 20 minutes after block needle insertion
measure: Pulse wave transit time
timeFrame: During 5 minutes before the end of the acclimatization period
measure: Pulse wave transit time
timeFrame: Between 5 and 10 minutes after block needle insertion
measure: Pulse wave transit time
timeFrame: Between 15 and 20 minutes after block needle insertion
measure: Sensory blockade
timeFrame: 20 minutes after block needle insertion
measure: Motor blockade
timeFrame: 20 minutes after block needle insertion
measure: Bilateral pupil diameters
timeFrame: Within 1 minute after acclimatization
measure: Bilateral pupil diameters
timeFrame: 20 minutes after block needle insertion
measure: Incidence of side effects related to interscalene brachial plexus block
timeFrame: 20 minutes after block needle insertion
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
Study officials:
affiliation: Daegu Catholic University Medical Center
name: Jonghae Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References: