NCT06015204已完成不适用
Objective Assessment of Extent of Anesthesia in the 8th Cervical Dermatome Using Photoplethysmographic Amplitude in Patients Undergoing Interscalene Brachial Plexus Block
JongHae Kim2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2023年9月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Time to achieve 50% of maximum photoplethysmographic amplitude measured from the 5th finger
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical status 1 or 2
- •Schedule to receive interscalene brachial plexus block for arthroscopic shoulder surgery
排除标准
- •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
结局指标
主要结局
Time to achieve 50% of maximum photoplethysmographic amplitude measured from the 5th finger
时间窗: 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.
次要结局
- Time to achieve 90% of maximum photoplethysmographic amplitude measured from the 1st finger(25 minutes after the introduction of a block needle)
- Sensory blockade of the C7 dermatome(30 minutes after the introduction of a block needle)
- Motor blockade of elbow flexion(30 minutes after the introduction of a block needle)
- 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 95% 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 10% of maximum photoplethysmographic amplitude measured from the 1st finger(25 minutes after the introduction of a block needle)
- Baseline blood flow measured from the radial artery ipsilateral to interscalene brachial plexus block(15 minutes before the introduction of a block needle)
- Baseline blood flow measured from the ulnar artery ipsilateral to interscalene brachial plexus block(15 minutes before the introduction of a block needle)
- Sensory blockade of the C6 dermatome(30 minutes after the introduction of a block needle)
- Motor blockade of finger abduction(30 minutes after the introduction of a block needle)
- Time to achieve 5% of maximum photoplethysmographic amplitude measured from the 1st finger(25 minutes after the introduction of a block needle)
- Post-block blood flow measured from the radial artery ipsilateral to interscalene brachial plexus block(25 minutes after the introduction of a block needle)
- Sensory blockade of the C5 dermatome(30 minutes after the introduction of a block needle)
- Sensory blockade of the C8 dermatome(30 minutes after the introduction of a block needle)
- Motor blockade of forearm supination(30 minutes after the introduction of a block needle)
- Motor blockade of thumb adduction(30 minutes after the introduction of a block needle)
- Post-block pupil diameter ipsilateral to interscalene brachial plexus block(35 minutes after the introduction of a block needle)
- Pain upon surgical incision (1.5-3 cm inferior and medial to the posterolateral tip of the acromion)(An average of 1 hour 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)
- Time to achieve 50% of maximum photoplethysmographic amplitude measured from the 1st finger(25 minutes after the introduction of a block needle)
- Time to achieve 95% of maximum photoplethysmographic amplitude measured from the 1st finger(25 minutes after the introduction of a block needle)
- Time to achieve 99% of maximum photoplethysmographic amplitude measured from the 1st finger(25 minutes after the introduction of a block needle)
- Post-block blood flow measured from the brachial artery ipsilateral to interscalene brachial plexus block(25 minutes after the introduction of a block needle)
- Motor blockade of shoulder abduction(30 minutes after the introduction of a block needle)
- Motor blockade of forearm pronation(30 minutes after the introduction of a block needle)
- Baseline pupil diameter ipsilateral to interscalene brachial plexus block(5 minutes before the introduction of a block needle)
- Baseline blood flow measured from the brachial artery ipsilateral to interscalene brachial plexus block(15 minutes before the introduction of a block needle)
- Post-block blood flow measured from the ulnar artery ipsilateral to interscalene brachial plexus block(25 minutes after the introduction of a block needle)
- Sensory blockade of the T1 dermatome(30 minutes 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)(1 minute after surgical incision)
- Motor blockade of thumb abduction(30 minutes after the introduction of a block needle)
- Post-block pupil diameter contralateral to interscalene brachial plexus block(35 minutes after the introduction of a block needle)
- Motor blockade of thumb opposition(30 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)(1 minute before the surgical incision)
- Baseline pupil diameter contralateral to interscalene brachial plexus block(5 minutes before the introduction of a block needle)
研究者
JongHae Kim
Professor
Daegu Catholic University Medical Center
研究点 (2)
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