Assessment of the C8 Dermatomal Block With Photoplethysmographic Amplitude After Interscalene Brachial Plexus Block

Brachial Plexus Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06015204
• Other study ID #: 2023-02
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2023
• Est. completion date: August 2024

Study information

• Verified date: September 2023
• Source: Daegu Catholic University Medical Center
• Contact: Jonghae Kim, M.D.
• Phone: +82-10-3360-4885
• Email: usmed12[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

• Infection at 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

• Severe restrictive pulmonary disorder

• Electrolyte imbalance

• Difficulty in communicating with medical personnel

• Patients refusal

Related Conditions & MeSH terms

• Brachial Plexus Block
• Oximetry

Intervention

Procedure:
• Interscalene brachial plexus block targeting the C5-to-C6 nerve roots
With the head rotated contralateral to interscalene brachial plexus block (ISBPB), the compactly arranged brachial plexus is visualized lateral to the pulsating subclavian artery under ultrasound guidance. The linear ultrasound transducer is moved cephalad until the C5-to-C8 nerve roots are visualized between the anterior and middle scalene muscles. A block needle is introduced from lateral to medial direction. A nerve root is blocked by placing at least 5 ml of 0.75% ropivacaine around it. The most caudal cervical nerve root (C6 nerve root) is blocked first, and the most cephalad one (C5 nerve root) is blocked last. Then, 3 ml of 0.75% ropivacaine is placed between the scalene and sternocleidomastoid muscles to block the supraclavicular nerves. An equivalent volume of a standard study drug is planned to be used (A total of 25 ml of 0.75% ropivacaine).
• Interscalene brachial plexus block targeting the C5-to-C8 nerve roots
With the head rotated contralateral to interscalene brachial plexus block (ISBPB), the compactly arranged brachial plexus is visualized lateral to the pulsating subclavian artery under ultrasound guidance. The linear ultrasound transducer is moved cephalad until the C5-to-C8 nerve roots are visualized between the anterior and middle scalene muscles. A block needle is introduced from lateral to medial direction. A nerve root is blocked by placing at least 5 ml of 0.75% ropivacaine around it. The most caudal cervical nerve root (C8 nerve root) is blocked first, and the most cephalad one (C5 nerve root) is blocked last. Then, 3 ml of 0.75% ropivacaine is placed between the scalene and sternocleidomastoid muscles to block the supraclavicular nerves. An equivalent volume of a standard study drug is planned to be used (A total of 25 ml of 0.75% ropivacaine).

Locations

Country	Name	City	State
Korea, Republic of	Daegu Catholic University Medical Center	Daegu

Sponsors (2)

Lead Sponsor	Collaborator
JongHae Kim	Research Institute of Medical Science, Daegu Catholic University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications related to interscalene brachial plexus block	Accidental puncture of the common carotid, subclavian, or vertebral artery, pneumo/hemothorax, epidural or intrathecal injection of local anesthetic, local anesthetic systemic toxicity, and other neurological complications	35 minutes after the introduction of a block needle
Other	Baseline systolic blood pressure	Measured with a non-invasive blood pressure cuff	5 minutes before the introduction of a block needle
Other	Post-block systolic blood pressure	Measured with a non-invasive blood pressure cuff	35 minutes after the introduction of a block needle
Other	Baseline heart rate	Measured from electrocardiogram	5 minutes before the introduction of a block needle
Other	Post-block heart rate	Measured from electrocardiogram	35 minutes after the introduction of a block needle
Primary	Time to achieve 50% of maximum photoplethysmographic amplitude measured from the 5th finger	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.	25 minutes after the introduction of a block needle
Secondary	Time to achieve 5% of maximum photoplethysmographic amplitude measured from the 5th finger	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 5% of maximum photoplethysmographic amplitude is achieved, can be derived.	25 minutes after the introduction of a block needle
Secondary	Time to achieve 10% of maximum photoplethysmographic amplitude measured from the 5th finger	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 10% of maximum photoplethysmographic amplitude is achieved, can be derived.	25 minutes after the introduction of a block needle
Secondary	Time to achieve 90% of maximum photoplethysmographic amplitude measured from the 5th finger	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 90% of maximum photoplethysmographic amplitude is achieved, can be derived.	25 minutes after the introduction of a block needle
Secondary	Time to achieve 95% of maximum photoplethysmographic amplitude measured from the 5th finger	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 95% of maximum photoplethysmographic amplitude is achieved, can be derived.	25 minutes after the introduction of a block needle
Secondary	Time to achieve 99% of maximum photoplethysmographic amplitude measured from the 5th finger	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 99% of maximum photoplethysmographic amplitude is achieved, can be derived.	25 minutes after the introduction of a block needle
Secondary	Time to achieve 5% of maximum photoplethysmographic amplitude measured from the 1st finger	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 5% of maximum photoplethysmographic amplitude is achieved, can be derived.	25 minutes after the introduction of a block needle
Secondary	Time to achieve 10% of maximum photoplethysmographic amplitude measured from the 1st finger	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 10% of maximum photoplethysmographic amplitude is achieved, can be derived.	25 minutes after the introduction of a block needle
Secondary	Time to achieve 50% of maximum photoplethysmographic amplitude measured from the 1st finger	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.	25 minutes after the introduction of a block needle
Secondary	Time to achieve 90% of maximum photoplethysmographic amplitude measured from the 1st finger	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 90% of maximum photoplethysmographic amplitude is achieved, can be derived.	25 minutes after the introduction of a block needle
Secondary	Time to achieve 95% of maximum photoplethysmographic amplitude measured from the 1st finger	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 95% of maximum photoplethysmographic amplitude is achieved, can be derived.	25 minutes after the introduction of a block needle
Secondary	Time to achieve 99% of maximum photoplethysmographic amplitude measured from the 1st finger	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 99% of maximum photoplethysmographic amplitude is achieved, can be derived.	25 minutes after the introduction of a block needle
Secondary	Baseline blood flow measured from the brachial artery ipsilateral to interscalene brachial plexus block	The linear ultrasound transducer is placed parallel with the brachial artery at the antecubital fossa. Using pulse wave Doppler ultrasound, time velocity integral per heartbeat is calculated. The cross-sectional diameter of the artery is measured with the transducer placed transversely to the artery. The blood flow of the artery (ml/min) is the product of the averaged time velocity integral (cm), cross-sectional area of the artery (cm2), and heart rate (beats/min).	15 minutes before the introduction of a block needle
Secondary	Baseline blood flow measured from the radial artery ipsilateral to interscalene brachial plexus block	The linear ultrasound transducer is placed parallel with the radial artery at the distal forearm area. Using pulse wave Doppler ultrasound, time velocity integral per heartbeat is calculated. The cross-sectional diameter of the artery is measured with the transducer placed transversely to the artery. The blood flow of the artery (ml/min) is the product of the averaged time velocity integral (cm), cross-sectional area of the artery (cm2), and heart rate (beats/min).	15 minutes before the introduction of a block needle
Secondary	Baseline blood flow measured from the ulnar artery ipsilateral to interscalene brachial plexus block	The linear ultrasound transducer is placed parallel with the ulnar artery at the distal forearm area. Using pulse wave Doppler ultrasound, time velocity integral per heartbeat is calculated. The cross-sectional diameter of the artery is measured with the transducer placed transversely to the artery. The blood flow of the artery (ml/min) is the product of the averaged time velocity integral (cm), cross-sectional area of the artery (cm2), and heart rate (beats/min).	15 minutes before the introduction of a block needle
Secondary	Post-block blood flow measured from the brachial artery ipsilateral to interscalene brachial plexus block	The linear ultrasound transducer is placed parallel with the brachial artery at the antecubital fossa. Using pulse wave Doppler ultrasound, time velocity integral per heartbeat is calculated. The cross-sectional diameter of the artery is measured with the transducer placed transversely to the artery. The blood flow of the artery (ml/min) is the product of the averaged time velocity integral (cm), cross-sectional area of the artery (cm2), and heart rate (beats/min).	25 minutes after the introduction of a block needle
Secondary	Post-block blood flow measured from the radial artery ipsilateral to interscalene brachial plexus block	The linear ultrasound transducer is placed parallel with the radial artery at the distal forearm area. Using pulse wave Doppler ultrasound, time velocity integral per heartbeat is calculated. The cross-sectional diameter of the artery is measured with the transducer placed transversely to the artery. The blood flow of the artery (ml/min) is the product of the averaged time velocity integral (cm), cross-sectional area of the artery (cm2), and heart rate (beats/min).	25 minutes after the introduction of a block needle
Secondary	Post-block blood flow measured from the ulnar artery ipsilateral to interscalene brachial plexus block	The linear ultrasound transducer is placed parallel with the ulnar artery at the distal forearm area. Using pulse wave Doppler ultrasound, time velocity integral per heartbeat is calculated. The cross-sectional diameter of the artery is measured with the transducer placed transversely to the artery. The blood flow of the artery (ml/min) is the product of the averaged time velocity integral (cm), cross-sectional area of the artery (cm2), and heart rate (beats/min).	25 minutes after the introduction of a block needle
Secondary	Sensory blockade of the C5 dermatome	Using an alcohol swab, the sensory blockade of each dermatome is graded as 0 (no cold sensation), 1 (reduced cold sensation), 2 (normal cold sensation).	30 minutes after the introduction of a block needle
Secondary	Sensory blockade of the C6 dermatome	Using an alcohol swab, the sensory blockade of each dermatome is graded as 0 (no cold sensation), 1 (reduced cold sensation), 2 (normal cold sensation).	30 minutes after the introduction of a block needle
Secondary	Sensory blockade of the C7 dermatome	Using an alcohol swab, the sensory blockade of each dermatome is graded as 0 (no cold sensation), 1 (reduced cold sensation), 2 (normal cold sensation).	30 minutes after the introduction of a block needle
Secondary	Sensory blockade of the C8 dermatome	Using an alcohol swab, the sensory blockade of each dermatome is graded as 0 (no cold sensation), 1 (reduced cold sensation), 2 (normal cold sensation).	30 minutes after the introduction of a block needle
Secondary	Sensory blockade of the T1 dermatome	Using an alcohol swab, the sensory blockade of each dermatome is graded as 0 (no cold sensation), 1 (reduced cold sensation), 2 (normal cold sensation).	30 minutes after the introduction of a block needle
Secondary	Motor blockade of shoulder abduction	Motor blockade is assessed by rating the force of movement corresponding to each nerve as 0 (complete block), 1 (partial block), or 2 (no block).	30 minutes after the introduction of a block needle
Secondary	Motor blockade of elbow flexion	Motor blockade is assessed by rating the force of movement corresponding to each nerve as 0 (complete block), 1 (partial block), or 2 (no block).	30 minutes after the introduction of a block needle
Secondary	Motor blockade of forearm supination	Motor blockade is assessed by rating the force of movement corresponding to each nerve as 0 (complete block), 1 (partial block), or 2 (no block).	30 minutes after the introduction of a block needle
Secondary	Motor blockade of forearm pronation	Motor blockade is assessed by rating the force of movement corresponding to each nerve as 0 (complete block), 1 (partial block), or 2 (no block).	30 minutes after the introduction of a block needle
Secondary	Motor blockade of finger abduction	Motor blockade is assessed by rating the force of movement corresponding to each nerve as 0 (complete block), 1 (partial block), or 2 (no block).	30 minutes after the introduction of a block needle
Secondary	Motor blockade of thumb abduction	Motor blockade is assessed by rating the force of movement corresponding to each nerve as 0 (complete block), 1 (partial block), or 2 (no block).	30 minutes after the introduction of a block needle
Secondary	Motor blockade of thumb adduction	Motor blockade is assessed by rating the force of movement corresponding to each nerve as 0 (complete block), 1 (partial block), or 2 (no block).	30 minutes after the introduction of a block needle
Secondary	Motor blockade of thumb opposition	Motor blockade is assessed by rating the force of movement corresponding to each nerve as 0 (complete block), 1 (partial block), or 2 (no block).	30 minutes after the introduction of a block needle
Secondary	Baseline pupil diameter ipsilateral to interscalene brachial plexus block	Three minutes after the adaptation in low mesopic conditions, the pupil diameter is measured for 2 seconds at 30 Hz using a portable pupillometer. The pupil diameter is obtained by averaging 60 measurement values.	5 minutes before the introduction of a block needle
Secondary	Baseline pupil diameter contralateral to interscalene brachial plexus block	Three minutes after the adaptation in low mesopic conditions, the pupil diameter is measured for 2 seconds at 30 Hz using a portable pupillometer. The pupil diameter is obtained by averaging 60 measurement values.	5 minutes before the introduction of a block needle
Secondary	Post-block pupil diameter ipsilateral to interscalene brachial plexus block	Three minutes after the adaptation in low mesopic conditions, the pupil diameter is measured for 2 seconds at 30 Hz using a portable pupillometer. The pupil diameter is obtained by averaging 60 measurement values.	35 minutes after the introduction of a block needle
Secondary	Post-block pupil diameter contralateral to interscalene brachial plexus block	Three minutes after the adaptation in low mesopic conditions, the pupil diameter is measured for 2 seconds at 30 Hz using a portable pupillometer. The pupil diameter is obtained by averaging 60 measurement values.	35 minutes after the introduction of a block needle
Secondary	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)	The pain intensity is rated as 0 (no pain), 1 (mild pain), and 2 (severe pain).	1 minute before the surgical incision
Secondary	Pain upon surgical incision (1.5-3 cm inferior and medial to the posterolateral tip of the acromion)	The pain intensity is rated as 0 (no pain), 1 (mild pain), and 2 (severe pain).	An average of 1 hour after the introduction of a block needle
Secondary	Pain upon posterior portal placement (1.5-3 cm inferior and medial to the posterolateral tip of the acromion)	The pain intensity is rated as 0 (no pain), 1 (mild pain), and 2 (severe pain).	1 minute after surgical incision