Effect of Remote Local Peripheral Nerve Cooling on Pain of Arterial Puncture
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Skin cooling to 20°C, Skin cooling to 15°C, Skin cooling to 8°C, No skin cooling.
- Кому может быть актуально
- Состояния в реестре: Acute Pain. Базовые параметры: Без ограничений · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Вмешательства
- Процедура Skin cooling to 20°C
According to the group, copper parts at a constant temperature of 20°C were placed on the superficial skin of the brachial plexus for 15 minutes. - Процедура Skin cooling to 15°C
According to the group, copper parts at a constant temperature of 15°C were placed on the superficial skin of the brachial plexus for 15 minutes. - Процедура Skin cooling to 8°C
According to the group, copper parts at a constant temperature of 8°C were placed on the superficial skin of the brachial plexus for 15 minutes. - Процедура No skin cooling
According to the group, copper parts at room temperature (23°C) were placed on the superficial skin of the brachial plexus for 15 minutes.
Первичные конечные точки
- Visual Analogue Pain Scale (VAS) score of arterial puncture procedure [Срок оценки: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.]
Вторичные конечные точки (12)
- Pressure pain threshold [Срок оценки: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.]
- Pressure pain tolerance [Срок оценки: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.]
- The average perfusion [Срок оценки: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.]
- The median perfusion [Срок оценки: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.]
- The maximum perfusion [Срок оценки: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.]
- The minimum perfusion [Срок оценки: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.]
- The approximate depth of the right brachial plexus. [Срок оценки: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.]
- Depth of the Right Radial Artery [Срок оценки: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.]
- Peak Systolic Velocity (PS) [Срок оценки: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.]
- End Diastolic Velocity (ED) [Срок оценки: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.]
- Time-Averaged Maximum Velocity (TAMAX) [Срок оценки: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.]
- Time-Averaged Mean Velocity (TAMEAN) [Срок оценки: From 0 to 3 hours after the volunteers enter the pre-anesthesia holding area.]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- The Second Affiliated Hospital of Chongqing Medical University — Чунцин
Идентификаторы
NCT: NCT06838572 · HH123