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

NCT06015204 | Completed

• 1 other identifier: 2023-02
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Brachial Plexus Block; Oximetry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (37)

• 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 90% 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 99% of maximum photoplethysmographic amplitude measured from the 5th finger

  25 minutes after the introduction of a block needle

Other Outcomes (5)

• Complications related to interscalene brachial plexus block

  35 minutes after the introduction of a block needle

• Baseline systolic blood pressure

  5 minutes before the introduction of a block needle

• Post-block systolic blood pressure

  35 minutes after the introduction of a block needle

Study Arms (2)

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.

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.

Procedure: Interscalene brachial plexus block targeting the C5-to-C8 nerve roots

Interventions

Interscalene brachial plexus block targeting the C5-to-C6 nerve roots PROCEDURE

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).

C5-C6 group

Interscalene brachial plexus block targeting the C5-to-C8 nerve roots PROCEDURE

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).

C5-C8 group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• JongHae Kim: lead
• Research Institute of Medical Science, Daegu Catholic University: collaborator

Study Sites (1)

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

Location

Study Officials

• Jonghae Kim, M.D.

  Daegu Catholic University School of Medicine, Daegu, Republic of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 29, 2023
• Study Start: September 13, 2023
• Primary Completion: August 28, 2024
• Study Completion: August 28, 2024
• Last Updated: February 6, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)