SPARK Study - Sympathetic PeriArterial Radial blocK Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pulse amplitude index (PAI)
研究概览
简要总结
The SPARK Study evaluates changes in peripheral sympathetic vasomotor activity following a targeted, ultrasound-guided periarterial sympathetic block of the distal radial artery in healthy volunteers. Autonomic reactivity will be assessed before and after the block using digit-specific pulse-amplitude index and infrared thermography during standardized cold pressor testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-50 years
- •ASA physical status I-II
- •Able to understand and provide informed consent
- •Able to comply with study procedures and follow-up
- •Two hands with 5 intact digits and no significant upper extremity injury
排除标准
- •Allergy to lidocaine or similar anesthetics
- •Allergy to adhesives or ultrasound gel
- •Neuromuscular, autonomic, or major vascular disorders affecting upper extremities
- •Peripheral neuropathy
- •Raynaud's phenomenon or digital ischemia
- •Coagulopathy or anticoagulation
- •Active skin infection near block site
- •Pregnancy
- •BMI > 35 kg/m²
- •Inability to tolerate cold exposure
- •Any condition interfering with study conduct
研究组 & 干预措施
Left Wrist Block
Ultrasound-guided periarterial block with 2% lidocaine at left wrist.
干预措施: Lidocaine 2% (Drug)
Right Wrist Block
Ultrasound-guided periarterial block with 2% lidocaine at right wrist.
干预措施: Lidocaine 2% (Drug)
结局指标
主要结局
Pulse amplitude index (PAI)
时间窗: PAI will be measured at: 1) Baseline; 2) after the first cold pressor test at 0, 5, 10, and 15 minutes; 3) after the sympathetic block at 5 and 10 minutes; 4) after the second cold pressor test at 0, 5, 10, and 15 minutes.
Pulse Amplitude Index (PAI) is a noninvasive measure of digital perfusion derived from photoplethysmography (PPG) signals recorded from the fingers. PAI reflects changes in pulse waveform amplitude and serves as an indirect marker of peripheral blood flow and sympathetic vasomotor tone. In this study, PAI will be continuously recorded using digital sensors placed on the index and fifth fingers of the hand undergoing periarterial radial block, as well as the contralateral index finger. Measurements will be obtained at baseline, following cold pressor testing, after the periarterial radial block, and following repeat cold pressor testing. Changes in PAI across time points will be used to assess alterations in peripheral perfusion associated with sympathetic modulation.
Hand temperature
时间窗: Thermal images will be obtained at: 1) Baseline; 2) after the first cold pressor test at 0, 5, 10, and 15 minutes; 3) after the sympathetic block at 5 and 10 minutes; 4) after the second cold pressor test at 0, 5, 10, and 15 minutes.
Hand temperature is a noninvasive measure of peripheral skin temperature used as an indicator of changes in local blood flow and sympathetic vasomotor activity. In this study, hand temperature will be assessed using infrared thermographic imaging of both hands. Thermal images will be acquired under standardized environmental conditions at baseline, following cold pressor testing, after the periarterial radial block, and following repeat cold pressor testing. Temperature values will be derived from predefined regions of interest on the hands based on arterial territories, and compared across time points to evaluate changes in peripheral perfusion associated with sympathetic modulation.
次要结局
- Temporal Changes in Cold Pressor Test-Induced Vasomotor Responses Pre- and Post-Block(Data will be obtained at: 1) Baseline; 2) after the first cold pressor test at 0, 5, 10, and 15 minutes; 3) after the sympathetic block at 5 and 10 minutes; 4) after the second cold pressor test at 0, 5, 10, and 15 minutes.)
- Change in Vasomotor Measures in the Fifth Finger(PAI and thermal images will be measured at: 1) Baseline; 2) after the first cold pressor test at 0, 5, 10, and 15 minutes; 3) after the sympathetic block at 5 and 10 minutes; 4) after the second cold pressor test at 0, 5, 10, and 15 minutes.)
- Change in Vasomotor Measures in the Contralateral Index Finger(PAI and thermal images will be measured at: 1) Baseline; 2) after the first cold pressor test at 0, 5, 10, and 15 minutes; 3) after the sympathetic block at 5 and 10 minutes; 4) after the second cold pressor test at 0, 5, 10, and 15 minutes.)