Clinical trial NCT06015204: Assessment of the C8 Dermatomal Block with Photoplethysmographic Amplitude After Interscalene Brachial Plexus Block
Official title: Objective Assessment of Extent of Anesthesia in the 8th Cervical Dermatome Using Photoplethysmographic Amplitude in Patients Undergoing Interscalene Brachial Plexus Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brachial Plexus Block
Oximetry
Lead sponsor: Daegu Catholic University Medical Center
Sponsor class: OTHER
Collaborators: name: Research Institute of Medical Science, Daegu Catholic University
First posted: 2023-08-29
Enrollment: 98
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Time to achieve 50% of maximum photoplethysmographic amplitude measured from the 5th finger
timeFrame: 25 minutes after the introduction of a block needle
Secondary outcomes:
measure: Time to achieve 5% of maximum photoplethysmographic amplitude measured from the 5th finger
timeFrame: 25 minutes after the introduction of a block needle
measure: Time to achieve 10% of maximum photoplethysmographic amplitude measured from the 5th finger
timeFrame: 25 minutes after the introduction of a block needle
measure: Time to achieve 90% of maximum photoplethysmographic amplitude measured from the 5th finger
timeFrame: 25 minutes after the introduction of a block needle
measure: Time to achieve 95% of maximum photoplethysmographic amplitude measured from the 5th finger
timeFrame: 25 minutes after the introduction of a block needle
measure: Time to achieve 99% of maximum photoplethysmographic amplitude measured from the 5th finger
timeFrame: 25 minutes after the introduction of a block needle
measure: Time to achieve 5% of maximum photoplethysmographic amplitude measured from the 1st finger
timeFrame: 25 minutes after the introduction of a block needle
measure: Time to achieve 10% of maximum photoplethysmographic amplitude measured from the 1st finger
timeFrame: 25 minutes after the introduction of a block needle
measure: Time to achieve 50% of maximum photoplethysmographic amplitude measured from the 1st finger
timeFrame: 25 minutes after the introduction of a block needle
measure: Time to achieve 90% of maximum photoplethysmographic amplitude measured from the 1st finger
timeFrame: 25 minutes after the introduction of a block needle
measure: Time to achieve 95% of maximum photoplethysmographic amplitude measured from the 1st finger
timeFrame: 25 minutes after the introduction of a block needle
measure: Time to achieve 99% of maximum photoplethysmographic amplitude measured from the 1st finger
timeFrame: 25 minutes after the introduction of a block needle
measure: Baseline blood flow measured from the brachial artery ipsilateral to interscalene brachial plexus block
timeFrame: 15 minutes before the introduction of a block needle
measure: Baseline blood flow measured from the radial artery ipsilateral to interscalene brachial plexus block
timeFrame: 15 minutes before the introduction of a block needle
measure: Baseline blood flow measured from the ulnar artery ipsilateral to interscalene brachial plexus block
timeFrame: 15 minutes before the introduction of a block needle
measure: Post-block blood flow measured from the brachial artery ipsilateral to interscalene brachial plexus block
timeFrame: 25 minutes after the introduction of a block needle
measure: Post-block blood flow measured from the radial artery ipsilateral to interscalene brachial plexus block
timeFrame: 25 minutes after the introduction of a block needle
measure: Post-block blood flow measured from the ulnar artery ipsilateral to interscalene brachial plexus block
timeFrame: 25 minutes after the introduction of a block needle
measure: Sensory blockade of the C5 dermatome
timeFrame: 30 minutes after the introduction of a block needle
measure: Sensory blockade of the C6 dermatome
timeFrame: 30 minutes after the introduction of a block needle
measure: Sensory blockade of the C7 dermatome
timeFrame: 30 minutes after the introduction of a block needle
measure: Sensory blockade of the C8 dermatome
timeFrame: 30 minutes after the introduction of a block needle
measure: Sensory blockade of the T1 dermatome
timeFrame: 30 minutes after the introduction of a block needle
measure: Motor blockade of shoulder abduction
timeFrame: 30 minutes after the introduction of a block needle
measure: Motor blockade of elbow flexion
timeFrame: 30 minutes after the introduction of a block needle
measure: Motor blockade of forearm supination
timeFrame: 30 minutes after the introduction of a block needle
measure: Motor blockade of forearm pronation
timeFrame: 30 minutes after the introduction of a block needle
measure: Motor blockade of finger abduction
timeFrame: 30 minutes after the introduction of a block needle
measure: Motor blockade of thumb abduction
timeFrame: 30 minutes after the introduction of a block needle
measure: Motor blockade of thumb adduction
timeFrame: 30 minutes after the introduction of a block needle
measure: Motor blockade of thumb opposition
timeFrame: 30 minutes after the introduction of a block needle
measure: Baseline pupil diameter ipsilateral to interscalene brachial plexus block
timeFrame: 5 minutes before the introduction of a block needle
measure: Baseline pupil diameter contralateral to interscalene brachial plexus block
timeFrame: 5 minutes before the introduction of a block needle
measure: Post-block pupil diameter ipsilateral to interscalene brachial plexus block
timeFrame: 35 minutes after the introduction of a block needle
measure: Post-block pupil diameter contralateral to interscalene brachial plexus block
timeFrame: 35 minutes after the introduction of a block needle
measure: 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)
timeFrame: 1 minute before the surgical incision
measure: Pain upon surgical incision (1.5-3 cm inferior and medial to the posterolateral tip of the acromion)
timeFrame: An average of 1 hour after the introduction of a block needle
measure: Pain upon posterior portal placement (1.5-3 cm inferior and medial to the posterolateral tip of the acromion)
timeFrame: 1 minute after surgical incision
Other outcomes:
measure: Complications related to interscalene brachial plexus block
timeFrame: 35 minutes after the introduction of a block needle
measure: Baseline systolic blood pressure
timeFrame: 5 minutes before the introduction of a block needle
measure: Post-block systolic blood pressure
timeFrame: 35 minutes after the introduction of a block needle
measure: Baseline heart rate
timeFrame: 5 minutes before the introduction of a block needle
measure: Post-block heart rate
timeFrame: 35 minutes after the introduction of a block needle
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
Study officials:
affiliation: Daegu Catholic University School of Medicine, Daegu, Republic of Korea
name: Jonghae Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References: