Brachial Plexus BlockNCT06015204
Assessment of the C8 Dermatomal Block with Photoplethysmographic Amplitude After Interscalene Brachial Plexus Block
A study testing Interscalene brachial plexus block targeting the C5-to-C6 nerve roots and Interscalene brachial plexus block targeting the C5-to-C8 nerve roots in people with Brachial Plexus Block and Oximetry, run by JongHae Kim at 1 site in South Korea.
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). Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Brachial Plexus Block, Oximetry
- What is being tested?
- Interscalene brachial plexus block targeting the C5-to-C6 nerve roots and Interscalene brachial plexus block targeting the C5-to-C8 nerve roots
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Sep 2023to 28 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status 1 or 2
- Schedule to receive interscalene brachial plexus block for arthroscopic shoulder surgery
Who cannot join
- Coagulopathy
- Peripheral vascular diseases
- Arrhythmias
- Cardiac conduction abnormalities
- A history of medication affecting cardiac conduction
- Ischemic heart disease
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Objective Assessment of Extent of Anesthesia in the 8th Cervical Dermatome Using Photoplethysmographic Amplitude in Patients Undergoing Interscalene Brachial Plexus Block
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.
- Conditions
- Brachial Plexus Block, Oximetry
- Being tested
- Interscalene brachial plexus block targeting the C5-to-C6 nerve roots, Interscalene brachial plexus block targeting the C5-to-C8 nerve roots
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interscalene brachial plexus block targeting the C5-to-C6 nerve rootsProcedure or surgery
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 rootsProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| C5-C6 group | Active comparator | The C5-to-C6 nerve roots and supraclavicular nerves are blocked with 25 ml of 0.75% ropivacaine under ultrasound guidance. Receives: Procedure: Interscalene brachial plexus block targeting the C5-to-C6 nerve roots |
| C5-C8 group | Experimental | The C5-to-C8 nerve roots and supraclavicular nerves are blocked with 25 ml of 0.75% ropivacaine under ultrasound guidance. Receives: Procedure: Interscalene brachial plexus block targeting the C5-to-C8 nerve roots |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 25 minutes after the introduction of a block needle
Secondary outcomes (37)
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.
Measured: 25 minutes after the introduction of a block needle
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.
Measured: 25 minutes after the introduction of a block needle
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.
Measured: 25 minutes after the introduction of a block needle
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.
Measured: 25 minutes after the introduction of a block needle
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.
Measured: 25 minutes after the introduction of a block needle
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.
Measured: 25 minutes after the introduction of a block needle
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.
Measured: 25 minutes after the introduction of a block needle
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.
Measured: 25 minutes after the introduction of a block needle
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.
Measured: 25 minutes after the introduction of a block needle
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.
Measured: 25 minutes after the introduction of a block needle
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.
Measured: 25 minutes after the introduction of a block needle
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).
Measured: 15 minutes before the introduction of a block needle
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).
Measured: 15 minutes before the introduction of a block needle
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).
Measured: 15 minutes before the introduction of a block needle
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).
Measured: 25 minutes after the introduction of a block needle
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).
Measured: 25 minutes after the introduction of a block needle
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).
Measured: 25 minutes after the introduction of a block needle
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).
Measured: 30 minutes after the introduction of a block needle
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).
Measured: 30 minutes after the introduction of a block needle
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).
Measured: 30 minutes after the introduction of a block needle
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).
Measured: 30 minutes after the introduction of a block needle
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).
Measured: 30 minutes after the introduction of a block needle
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).
Measured: 30 minutes after the introduction of a block needle
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).
Measured: 30 minutes after the introduction of a block needle
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).
Measured: 30 minutes after the introduction of a block needle
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).
Measured: 30 minutes after the introduction of a block needle
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).
Measured: 30 minutes after the introduction of a block needle
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).
Measured: 30 minutes after the introduction of a block needle
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).
Measured: 30 minutes after the introduction of a block needle
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).
Measured: 30 minutes after the introduction of a block needle
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.
Measured: 5 minutes before the introduction of a block needle
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.
Measured: 5 minutes before the introduction of a block needle
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.
Measured: 35 minutes after the introduction of a block needle
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.
Measured: 35 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)
The pain intensity is rated as 0 (no pain), 1 (mild pain), and 2 (severe pain).
Measured: 1 minute before the surgical incision
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).
Measured: An average of 1 hour 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)
The pain intensity is rated as 0 (no pain), 1 (mild pain), and 2 (severe pain).
Measured: 1 minute after surgical incision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start13 Sep 2023
- Primary completion28 Aug 2024
- Study completion28 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brachial Plexus BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- JongHae Kim
- Sponsor type
- University, hospital or other
- Collaborators
- Research Institute of Medical Science, Daegu Catholic University
- Responsible party
- Sponsor-investigator, JongHae Kim, Daegu Catholic University Medical Center
- Investigators
- Jonghae Kim, M.D., Principal investigator, Daegu Catholic University School of Medicine, Daegu, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015204
- Sponsor's protocol ID
- 2023-02
- Status last verified
- Sep 2023
- First submitted
- 18 Aug 2023
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be provided upon reasonable requests to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Assessment of Extent of Anesthesia in the 8th Cervical Dermatome Using Photoplethysmographic Amplitude in Patients Undergoing Interscalene Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT06015204
- Acronym / sponsor ID
- 2023-02
- Conditions
- Brachial Plexus Block, Oximetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- JongHae KimUniversity, hospital or other
- Collaborators
- Research Institute of Medical Science, Daegu Catholic University
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C5-C6 group | Active comparator | Procedure: Interscalene brachial plexus block targeting the C5-to-C6 nerve rootsThe C5-to-C6 nerve roots and supraclavicular nerves are blocked with 25 ml of 0.75% ropivacaine under ultrasound guidance. |
| C5-C8 group | Experimental | Procedure: Interscalene brachial plexus block targeting the C5-to-C8 nerve rootsThe C5-to-C8 nerve roots and supraclavicular nerves are blocked with 25 ml of 0.75% ropivacaine under ultrasound guidance. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status 1 or 2
- Schedule to receive interscalene brachial plexus block for arthroscopic shoulder surgery
Key exclusion criteria (18 listed)
- Coagulopathy
- Peripheral vascular diseases
- Arrhythmias
- Cardiac conduction abnormalities
- A history of medication affecting cardiac conduction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interscalene brachial plexus block targeting the C5-to-C6 nerve rootsWith 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). | Procedure or surgery | C5-C6 group |
| Interscalene brachial plexus block targeting the C5-to-C8 nerve rootsWith 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). | Procedure or surgery | C5-C8 group |
Primary outcome
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.
37 secondary outcomes
Time to achieve 5% of maximum photoplethysmographic amplitude measured from the 5th finger
Time frame: 25 minutes after the introduction of a block needle
Time to achieve 10% of maximum photoplethysmographic amplitude measured from the 5th finger
Time frame: 25 minutes after the introduction of a block needle
Time to achieve 90% of maximum photoplethysmographic amplitude measured from the 5th finger
Time frame: 25 minutes after the introduction of a block needle
Time to achieve 95% of maximum photoplethysmographic amplitude measured from the 5th finger
Time frame: 25 minutes after the introduction of a block needle
Time to achieve 99% of maximum photoplethysmographic amplitude measured from the 5th finger
Time frame: 25 minutes after the introduction of a block needle
Time to achieve 5% of maximum photoplethysmographic amplitude measured from the 1st finger
Time frame: 25 minutes after the introduction of a block needle
Time to achieve 10% of maximum photoplethysmographic amplitude measured from the 1st finger
Time frame: 25 minutes after the introduction of a block needle
Time to achieve 50% of maximum photoplethysmographic amplitude measured from the 1st finger
Time frame: 25 minutes after the introduction of a block needle
Time to achieve 90% of maximum photoplethysmographic amplitude measured from the 1st finger
Time frame: 25 minutes after the introduction of a block needle
Time to achieve 95% of maximum photoplethysmographic amplitude measured from the 1st finger
Time frame: 25 minutes after the introduction of a block needle
Time to achieve 99% of maximum photoplethysmographic amplitude measured from the 1st finger
Time frame: 25 minutes after the introduction of a block needle
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
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
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
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
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
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
Sensory blockade of the C5 dermatome
Time frame: 30 minutes after the introduction of a block needle
Sensory blockade of the C6 dermatome
Time frame: 30 minutes after the introduction of a block needle
Sensory blockade of the C7 dermatome
Time frame: 30 minutes after the introduction of a block needle
Sensory blockade of the C8 dermatome
Time frame: 30 minutes after the introduction of a block needle
Sensory blockade of the T1 dermatome
Time frame: 30 minutes after the introduction of a block needle
Motor blockade of shoulder abduction
Time frame: 30 minutes after the introduction of a block needle
Motor blockade of elbow flexion
Time frame: 30 minutes after the introduction of a block needle
Motor blockade of forearm supination
Time frame: 30 minutes after the introduction of a block needle
Motor blockade of forearm pronation
Time frame: 30 minutes after the introduction of a block needle
Motor blockade of finger abduction
Time frame: 30 minutes after the introduction of a block needle
Motor blockade of thumb abduction
Time frame: 30 minutes after the introduction of a block needle
Motor blockade of thumb adduction
Time frame: 30 minutes after the introduction of a block needle
Motor blockade of thumb opposition
Time frame: 30 minutes after the introduction of a block needle
Baseline pupil diameter ipsilateral to interscalene brachial plexus block
Time frame: 5 minutes before the introduction of a block needle
Baseline pupil diameter contralateral to interscalene brachial plexus block
Time frame: 5 minutes before the introduction of a block needle
Post-block pupil diameter ipsilateral to interscalene brachial plexus block
Time frame: 35 minutes after the introduction of a block needle
Post-block pupil diameter contralateral to interscalene brachial plexus block
Time frame: 35 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)
Time frame: 1 minute before the surgical incision
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No. The data will be provided upon reasonable requests to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonghae Kim, M.D. principal investigator
Daegu Catholic University School of Medicine, Daegu, Republic of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interscalene brachial plexus block targeting the C5-to-C6 nerve roots and Interscalene brachial plexus block targeting the C5-to-C8 nerve roots in people with Brachial Plexus Block and Oximetry, run by JongHae Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to achieve 50% of maximum photoplethysmographic amplitude measured from the 5th finger (time frame: 25 minutes after the introduction of a block needle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.