Effect of Remote Local Peripheral Nerve Cooling on Pain of Arterial Puncture
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual Analogue Pain Scale (VAS) score of arterial puncture procedure
研究概览
简要总结
In this project, volunteers will be recruited to cool the superficial skin of the axillary brachial plexus away from the puncture point, resulting in local peripheral nerve cooling, and observe its impact on the pain of arterial puncture.To explore the local peripheral nerve cooling treatment can produce controllable and reversible analgesic effect even if away from the wound, and provide a new nonpharmaceutical analgesic mode for clinical.
详细描述
Arterial puncture is a common cause of iatrogenic pain and anxiety, which can lead to stress and arterial spasm, leading to puncture failure.Clinicians usually use pharmacology to treat acute pain, but it is often accompanied by circulatory and respiratory depression, abnormal coagulation function, edema, pruritus, nausea, vomiting, constipation, addiction, etc., which can lead to death, and doctors strictly restrict the use of indications.In addition to drugs, electrical, light, mechanical or thermal stimulation can produce local reversible blocking effect of the peripheral nerve.Temperature is a simple, controllable and reversible physical factor.Current studies have shown that cooling the peripheral nerve to 10-15°C for 10 minutes can relieve pain, and numbness can occur after 15 minutes.These results suggest that cooling the peripheral nerve of sensory innervation in the remote trauma area can reduce nerve conduction velocity and signal amplitude, and provide a new method for non-pharmaceutical analgesia.Local peripheral nerve cooling therapy is an attractive approach to blocking nociceptive information because it is non-addictive, reversible, and allows simultaneous electrophysiological monitoring of the blocked nerve.In this project, volunteers will be recruited to cool the superficial skin of the axillary brachial plexus away from the puncture point, resulting in local peripheral nerve cooling, and observe its impact on the pain of arterial puncture.To explore the local peripheral nerve cooling treatment can produce controllable and reversible analgesic effect even if away from pain stimulation, and provide a new nonpharmaceutical analgesic mode for clinical.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 ~ 65 years old;
- •ASA I-II level;
- •Patients with perioperative invasive arterial blood pressure monitoring;
- •Right-handed;
- •Allen test was normal (palm color quickly turned red or returned to normal within 10 seconds after release of ulnar artery pressure);
- •Participate voluntarily and be able to understand and sign informed consent.
排除标准
- •Patients with a history of musculoskeletal, vascular, neurological or psychiatric disorders;
- •Patients with a history of diabetes or other systemic diseases
- •Patients who used any analgesic medication within the month before and during the study;
- •Patients with a history of smoking, alcohol or drug addiction;
- •Paraesthesia, scar, redness, damage, rash, etc. exist in the skin of the patient in the test area;
- •Patients whose surgical area overlaps with the cooling treatment or puncture area;
- •Female subjects are menstruating.
研究组 & 干预措施
Skin cooling to 20°C
The superficial skin of the right brachial plexus (superficial skin of the axillary artery at the junction of the right pectoralis major and biceps) cooled to 20°C for 15 minutes.
After cooling, 1ml 2% lidocaine was injected into the superficial skin of the right radial artery.
After local anesthesia, right radial artery puncture catheterization was performed.
Immediately after the puncture, warm air at 35°C was applied to the cooling treatment area for 10 minutes, and the target temperature was the surface temperature of the area before cooling treatment.
干预措施: Skin cooling to 20°C (Procedure)
Skin cooling to 15°C
The superficial skin of the right brachial plexus (superficial skin of the axillary artery at the junction of the right pectoralis major and biceps) cooled to 15°C for 15 minutes.
After cooling, 1ml 2% lidocaine was injected into the superficial skin of the right radial artery.
After local anesthesia, right radial artery puncture catheterization was performed.
Immediately after the puncture, warm air at 35°C was applied to the cooling treatment area for 10 minutes, and the target temperature was the surface temperature of the area before cooling treatment.
干预措施: Skin cooling to 15°C (Procedure)
Skin cooling to 8°C
The superficial skin of the right brachial plexus (superficial skin of the axillary artery at the junction of the right pectoralis major and biceps) cooled to 8°C for 15 minutes.
After cooling, 1ml 2% lidocaine was injected into the superficial skin of the right radial artery.
After local anesthesia, right radial artery puncture catheterization was performed.
Immediately after the puncture, warm air at 35°C was applied to the cooling treatment area for 10 minutes, and the target temperature was the surface temperature of the area before cooling treatment.
干预措施: Skin cooling to 8°C (Procedure)
No skin cooling
The superficial skin of the right brachial plexus does not need to be cooled. After waiting 15 minutes, 1ml2% lidocaine was injected into the superficial skin of the right radial artery.
After local anesthesia, right radial artery puncture catheterization was performed.
There is no need to warm the radial artery after catheterization.
干预措施: No skin cooling (Procedure)
结局指标
主要结局
Visual Analogue Pain Scale (VAS) score of arterial puncture procedure
时间窗: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.
The larger values of the Visual Analogue Pain Scale (VAS) score of local anesthetic injection and the Visual Analogue Pain Scale (VAS) score of arterial puncture catheterization were taken as the Visual Analogue Pain Scale (VAS) score of the process of arterial puncture catheterization.(VAS ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable)
次要结局
- Pressure pain threshold(From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.)
- Pressure pain tolerance(From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.)
- The average perfusion(From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.)
- The median perfusion(From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.)
- The maximum perfusion(From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.)
- The minimum perfusion(From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.)
- The approximate depth of the right brachial plexus.(From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.)
- Depth of the Right Radial Artery(From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.)
- Peak Systolic Velocity (PS)(From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.)
- Time-Averaged Mean Velocity (TAMEAN)(From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.)
- End Diastolic Velocity (ED)(From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.)
- Time-Averaged Maximum Velocity (TAMAX)(From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.)
- Pulsatility Index (PI)(From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.)
- Resistance Index (RI)(From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.)
- Systolic/Diastolic Ratio (S/D)(From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.)
- Blood Flow Volume (VolFlow)(From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.)
- Vessel Diameter (Vas Diam)(From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.)
- Vessel Area (Vas Area)(From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.)
- Room Temperature (°C)(From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.)
- Skin Temperature at the Right Brachial Plexus Superficial Ice Pack Application Area (°C)(From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.)
- Skin Temperature at the Right Radial Artery Puncture Site (°C)(From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.)
- Superficial Skin Temperature at the Left Radial Artery (°C)(From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.)
- Complication(From 0 to 24 hours after the volunteers enter the pre-anesthesia holding area.)