Objective Assessment of Extent of Anesthesia in the 8th Cervical Dermatome Using Photoplethysmographic Amplitude in Patients Undergoing Interscalene Brachial Plexus Block

JongHae Kim1 site in 1 country98 target enrollmentSeptember 13, 2023

ConditionsBrachial Plexus Block Oximetry

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Brachial Plexus Block
Sponsor: JongHae Kim
Enrollment: 98
Locations: 1
Primary Endpoint: Time to achieve 50% of maximum photoplethysmographic amplitude measured from the 5th finger
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to investigate the effectiveness of photoplethysmographic amplitude in assessing the extent of anesthesia in the 8th cervical dermatome in patients undergoing interscalene brachial plexus block (ISBPB). The main question it aims to answer is

Is there any difference in the post-block changes in photoplethysmographic amplitude measured from the ipsilateral 5th finger (supplied by the 8th cervical nerve root) between ISBPBs targeting the C5-to-C6 nerve roots and the C5-to-C8 nerve roots?
Do the changes in photoplethysmographic amplitude represent the extent of anesthesia in the 8th cervical dermatome? Participants will receive either ISBPB targeting the C5-to-C6 nerve roots or the C5-to-C8 nerve roots, and then the changes in photoplethysmographic amplitude will be measured from the 5th finger ipsilateral to ISBPB.

Registry

clinicaltrials.gov

Start Date

September 13, 2023

End Date

August 28, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

JongHae Kim

Responsible Party

Sponsor Investigator

Principal Investigator

JongHae Kim

Professor

Daegu Catholic University Medical Center

Eligibility Criteria

Inclusion Criteria

•American Society of Anesthesiologists physical status 1 or 2
•Schedule to receive interscalene brachial plexus block for arthroscopic shoulder surgery

Exclusion Criteria

•Coagulopathy
•Peripheral vascular diseases
•Arrhythmias
•Cardiac conduction abnormalities
•A history of medication affecting cardiac conduction
•Ischemic heart disease
•Hypertension
•Diabetes mellitus
•Thyroid dysfunction
•Other medical conditions affecting autonomic nervous activity

Outcomes

Primary Outcomes

Time to achieve 50% of maximum photoplethysmographic amplitude measured from the 5th finger

Time Frame: 25 minutes after the introduction of a block needle

During the whole study period, the photoplethysmographic waveform obtained from the 1st and 5th fingers ipsilateral to interscalene brachial plexus block is recorded at 100 Hz. The photoplethysmographic amplitude is calculated by subtracting the valley amplitude from the peak amplitude of one heartbeat in photoplethysmographic waveform. Using all the photoplethysmographic amplitudes between 0 and 25 minutes after the introduction of a block needle, a sigmoid Emax model is built. From the model, the time point, when 50% of maximum photoplethysmographic amplitude is achieved, can be derived.

Secondary Outcomes

Time to achieve 90% of maximum photoplethysmographic amplitude measured from the 1st finger(25 minutes after the introduction of a block needle)
Sensory blockade of the C7 dermatome(30 minutes after the introduction of a block needle)
Motor blockade of elbow flexion(30 minutes after the introduction of a block needle)
Time to achieve 5% of maximum photoplethysmographic amplitude measured from the 5th finger(25 minutes after the introduction of a block needle)
Time to achieve 10% of maximum photoplethysmographic amplitude measured from the 5th finger(25 minutes after the introduction of a block needle)
Time to achieve 95% of maximum photoplethysmographic amplitude measured from the 5th finger(25 minutes after the introduction of a block needle)
Time to achieve 90% of maximum photoplethysmographic amplitude measured from the 5th finger(25 minutes after the introduction of a block needle)
Time to achieve 10% of maximum photoplethysmographic amplitude measured from the 1st finger(25 minutes after the introduction of a block needle)
Baseline blood flow measured from the radial artery ipsilateral to interscalene brachial plexus block(15 minutes before the introduction of a block needle)
Baseline blood flow measured from the ulnar artery ipsilateral to interscalene brachial plexus block(15 minutes before the introduction of a block needle)
Sensory blockade of the C6 dermatome(30 minutes after the introduction of a block needle)
Motor blockade of finger abduction(30 minutes after the introduction of a block needle)
Time to achieve 5% of maximum photoplethysmographic amplitude measured from the 1st finger(25 minutes after the introduction of a block needle)
Post-block blood flow measured from the radial artery ipsilateral to interscalene brachial plexus block(25 minutes after the introduction of a block needle)
Sensory blockade of the C5 dermatome(30 minutes after the introduction of a block needle)
Sensory blockade of the C8 dermatome(30 minutes after the introduction of a block needle)
Motor blockade of forearm supination(30 minutes after the introduction of a block needle)
Motor blockade of thumb adduction(30 minutes after the introduction of a block needle)
Post-block pupil diameter ipsilateral to interscalene brachial plexus block(35 minutes after the introduction of a block needle)
Pain upon surgical incision (1.5-3 cm inferior and medial to the posterolateral tip of the acromion)(An average of 1 hour after the introduction of a block needle)
Time to achieve 99% of maximum photoplethysmographic amplitude measured from the 5th finger(25 minutes after the introduction of a block needle)
Time to achieve 50% of maximum photoplethysmographic amplitude measured from the 1st finger(25 minutes after the introduction of a block needle)
Time to achieve 95% of maximum photoplethysmographic amplitude measured from the 1st finger(25 minutes after the introduction of a block needle)
Time to achieve 99% of maximum photoplethysmographic amplitude measured from the 1st finger(25 minutes after the introduction of a block needle)
Post-block blood flow measured from the brachial artery ipsilateral to interscalene brachial plexus block(25 minutes after the introduction of a block needle)
Motor blockade of shoulder abduction(30 minutes after the introduction of a block needle)
Motor blockade of forearm pronation(30 minutes after the introduction of a block needle)
Baseline pupil diameter ipsilateral to interscalene brachial plexus block(5 minutes before the introduction of a block needle)
Baseline blood flow measured from the brachial artery ipsilateral to interscalene brachial plexus block(15 minutes before the introduction of a block needle)
Post-block blood flow measured from the ulnar artery ipsilateral to interscalene brachial plexus block(25 minutes after the introduction of a block needle)
Sensory blockade of the T1 dermatome(30 minutes after the introduction of a block needle)
Pain upon posterior portal placement (1.5-3 cm inferior and medial to the posterolateral tip of the acromion)(1 minute after surgical incision)
Motor blockade of thumb abduction(30 minutes after the introduction of a block needle)
Post-block pupil diameter contralateral to interscalene brachial plexus block(35 minutes after the introduction of a block needle)
Motor blockade of thumb opposition(30 minutes after the introduction of a block needle)
Pain upon a pinch at the skin area for posterior portal placement (1.5-3 cm inferior and medial to the posterolateral tip of the acromion)(1 minute before the surgical incision)
Baseline pupil diameter contralateral to interscalene brachial plexus block(5 minutes before the introduction of a block needle)