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

• ClinicalTrials.gov Identifier: NCT06015204
• Recruitment Status: Recruiting
• First Posted: August 29, 2023
• Last Update Posted: September 14, 2023
• Sponsor: JongHae Kim
• Collaborator: Research Institute of Medical Science, Daegu Catholic University
• Information provided by (Responsible Party): JongHae Kim, Daegu Catholic University Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Brachial Plexus Block; Oximetry	Procedure: Interscalene brachial plexus block targeting the C5-to-C6 nerve roots; Procedure: Interscalene brachial plexus block targeting the C5-to-C8 nerve roots	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 98 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Objective Assessment of Extent of Anesthesia in the 8th Cervical Dermatome Using Photoplethysmographic Amplitude in Patients Undergoing Interscalene Brachial Plexus Block
• Actual Study Start Date: September 13, 2023
• Estimated Primary Completion Date: August 2024
• Estimated Study Completion Date: August 2024

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: C5-C6 group; The C5-to-C6 nerve roots and supraclavicular nerves are blocked with 25 ml of 0.75% ropivacaine under ultrasound guidance.	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).
Experimental: C5-C8 group; The C5-to-C8 nerve roots and supraclavicular nerves are blocked with 25 ml of 0.75% ropivacaine under ultrasound guidance.	Procedure: 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).

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Time to achieve 5% 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 5% of maximum photoplethysmographic amplitude is achieved, can be derived.
2. Time to achieve 10% 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 10% of maximum photoplethysmographic amplitude is achieved, can be derived.
3. Time to achieve 90% 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 90% of maximum photoplethysmographic amplitude is achieved, can be derived.
4. Time to achieve 95% 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 95% of maximum photoplethysmographic amplitude is achieved, can be derived.
5. Time to achieve 99% 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 99% of maximum photoplethysmographic amplitude is achieved, can be derived.
6. Time to achieve 5% of maximum photoplethysmographic amplitude measured from the 1st 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 5% of maximum photoplethysmographic amplitude is achieved, can be derived.
7. Time to achieve 10% of maximum photoplethysmographic amplitude measured from the 1st 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 10% of maximum photoplethysmographic amplitude is achieved, can be derived.
8. Time to achieve 50% of maximum photoplethysmographic amplitude measured from the 1st 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.
9. Time to achieve 90% of maximum photoplethysmographic amplitude measured from the 1st 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 90% of maximum photoplethysmographic amplitude is achieved, can be derived.
10. Time to achieve 95% of maximum photoplethysmographic amplitude measured from the 1st 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 95% of maximum photoplethysmographic amplitude is achieved, can be derived.
11. Time to achieve 99% of maximum photoplethysmographic amplitude measured from the 1st 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 99% of maximum photoplethysmographic amplitude is achieved, can be derived.
12. Baseline blood flow measured from the brachial artery ipsilateral to interscalene brachial plexus block [ Time Frame: 15 minutes before the introduction of a block needle ]
    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).
13. Baseline blood flow measured from the radial artery ipsilateral to interscalene brachial plexus block [ Time Frame: 15 minutes before the introduction of a block needle ]
    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).
14. Baseline blood flow measured from the ulnar artery ipsilateral to interscalene brachial plexus block [ Time Frame: 15 minutes before the introduction of a block needle ]
    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. Post-block blood flow measured from the brachial artery ipsilateral to interscalene brachial plexus block [ Time Frame: 25 minutes after the introduction of a block needle ]
    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).
16. Post-block blood flow measured from the radial artery ipsilateral to interscalene brachial plexus block [ Time Frame: 25 minutes after the introduction of a block needle ]
    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).
17. Post-block blood flow measured from the ulnar artery ipsilateral to interscalene brachial plexus block [ Time Frame: 25 minutes after the introduction of a block needle ]
    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).
18. Sensory blockade of the C5 dermatome [ Time Frame: 30 minutes after the introduction of a block needle ]
    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).
19. Sensory blockade of the C6 dermatome [ Time Frame: 30 minutes after the introduction of a block needle ]
    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).
20. Sensory blockade of the C7 dermatome [ Time Frame: 30 minutes after the introduction of a block needle ]
    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).
21. Sensory blockade of the C8 dermatome [ Time Frame: 30 minutes after the introduction of a block needle ]
    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).
22. Sensory blockade of the T1 dermatome [ Time Frame: 30 minutes after the introduction of a block needle ]
    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).
23. Motor blockade of shoulder abduction [ Time Frame: 30 minutes after the introduction of a block needle ]
    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).
24. Motor blockade of elbow flexion [ Time Frame: 30 minutes after the introduction of a block needle ]
    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).
25. Motor blockade of forearm supination [ Time Frame: 30 minutes after the introduction of a block needle ]
    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).
26. Motor blockade of forearm pronation [ Time Frame: 30 minutes after the introduction of a block needle ]
    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).
27. Motor blockade of finger abduction [ Time Frame: 30 minutes after the introduction of a block needle ]
    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).
28. Motor blockade of thumb abduction [ Time Frame: 30 minutes after the introduction of a block needle ]
    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).
29. Motor blockade of thumb adduction [ Time Frame: 30 minutes after the introduction of a block needle ]
    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. Motor blockade of thumb opposition [ Time Frame: 30 minutes after the introduction of a block needle ]
    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).
31. Baseline pupil diameter ipsilateral to interscalene brachial plexus block [ Time Frame: 5 minutes before the introduction of a block needle ]
    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.
32. Baseline pupil diameter contralateral to interscalene brachial plexus block [ Time Frame: 5 minutes before the introduction of a block needle ]
    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.
33. Post-block pupil diameter ipsilateral to interscalene brachial plexus block [ Time Frame: 35 minutes after the introduction of a block needle ]
    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.
34. Post-block pupil diameter contralateral to interscalene brachial plexus block [ Time Frame: 35 minutes after the introduction of a block needle ]
    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. 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) [ Time Frame: 1 minute before the surgical incision ]
    The pain intensity is rated as 0 (no pain), 1 (mild pain), and 2 (severe pain).
36. Pain upon surgical incision (1.5-3 cm inferior and medial to the posterolateral tip of the acromion) [ Time Frame: An average of 1 hour after the introduction of a block needle ]
    The pain intensity is rated as 0 (no pain), 1 (mild pain), and 2 (severe pain).
37. Pain upon posterior portal placement (1.5-3 cm inferior and medial to the posterolateral tip of the acromion) [ Time Frame: 1 minute after surgical incision ]
    The pain intensity is rated as 0 (no pain), 1 (mild pain), and 2 (severe pain).

Other Outcome Measures:

1. Complications related to interscalene brachial plexus block [ Time Frame: 35 minutes after the introduction of a block needle ]
   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
2. Baseline systolic blood pressure [ Time Frame: 5 minutes before the introduction of a block needle ]
   Measured with a non-invasive blood pressure cuff
3. Post-block systolic blood pressure [ Time Frame: 35 minutes after the introduction of a block needle ]
   Measured with a non-invasive blood pressure cuff
4. Baseline heart rate [ Time Frame: 5 minutes before the introduction of a block needle ]
   Measured from electrocardiogram
5. Post-block heart rate [ Time Frame: 35 minutes after the introduction of a block needle ]
   Measured from electrocardiogram

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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
• 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

Contacts and Locations

Contacts

Contact: Jonghae Kim, M.D.; +82-10-3360-4885; usmed12@gmail.com

Locations

Korea, Republic of

Daegu Catholic University Medical Center; Recruiting

Daegu, Korea, Republic of, 42472

Contact: Jonghae Kim, M.D. +82-10-3360-4885 usmed12@gmail.com

Sponsors and Collaborators

JongHae Kim

Research Institute of Medical Science, Daegu Catholic University

Investigators

• Principal Investigator: Jonghae Kim, M.D.; Daegu Catholic University School of Medicine, Daegu, Republic of Korea

More Information

• Responsible Party: JongHae Kim, Professor, Daegu Catholic University Medical Center
• ClinicalTrials.gov Identifier: NCT06015204
• Other Study ID Numbers: 2023-02
• First Posted: August 29, 2023
• Last Update Posted: September 14, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: The data will be provided upon reasonable requests to the principal investigator.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No