Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery
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: Tourniquet.
- Кому может быть актуально
- Состояния в реестре: Ankle Fractures, Ankle Fracture - Lateral Malleolus, Ankle Fracture, Bimalleolar, Ankle Fracture, Trimalleolar. Базовые параметры: 18 лет — 89 лет · 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
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This study aims to 1) characterize skeletal muscle pH during/after tourniquet use and 2) investigate any relationship between intraoperative tourniquet use and postoperative functional measures and patient-reported outcomes.
Подробное описание
Tourniquets are widely accepted as "safe" for up to two hours of continued use, despite known risks and a paucity of literature supporting this duration. Complications of tourniquets include tourniquet site pain, increased surgical site pain and swelling from reperfusion, neuropraxia, vascular injury, functional weakness, and decreased muscle endurance. Similar to compartment syndrome, tourniquets eliminate the tissue perfusion gradient necessary for oxygen, glucose, and lactic acid exchange. Lack of molecular exchange within the tissue is thought to result in tissue anoxia and acidosis, leading to cellular death of skeletal muscle and nerves. This study randomizes patients undergoing ankle fracture surgery to tourniquet or no-tourniquet arms and studies outcomes including continuous intramuscular pH during and after surgery, and patient-reported outcomes and functional measures up to 3 months postoperatively.
Вмешательства
- Процедура Tourniquet
This arm will have a tourniquet placed about the thigh and inflated to 250mmHg for the duration of ankle fracture surgery or 2 hours, whichever is shorter.
Первичные конечные точки
- Change from Baseline Patient-Reported Outcomes Measurement Information System Physical Function Subscale at 12 Weeks [Срок оценки: Collected preoperatively and 12 weeks postoperatively]
- Change from Baseline Patient-Reported Outcomes Measurement Information System Pain Interference Subscale at 12 weeks [Срок оценки: Collected preoperatively and 12 weeks postoperatively]
- Change from Baseline Foot and Ankle Ability Measure at 12 weeks [Срок оценки: Collected preoperatively and 12 weeks postoperatively]
Вторичные конечные точки (10)
- Pain Score [Срок оценки: Assessed preoperatively and at 2 hours and 3, 6 and 12 weeks postoperatively]
- Malleolar circumference [Срок оценки: Collected at 6 weeks and 12 weeks postoperatively]
- Calf girth [Срок оценки: Collected at 6 weeks and 12 weeks postoperatively]
- Mobility [Срок оценки: Collected at 6 weeks and 12 weeks postoperatively]
- Ankle range of motion [Срок оценки: Collected at 6 weeks and 12 weeks postoperatively]
- Fatigability [Срок оценки: Collected at 6 weeks and 12 weeks postoperatively]
- Proximal and distal lower extremity strength [Срок оценки: Collected at 6 weeks and 12 weeks postoperatively]
- Single-limb stance time [Срок оценки: Collected at 6 weeks and 12 weeks postoperatively]
- Y-balance test scores [Срок оценки: Collected at 6 weeks and 12 weeks postoperatively]
- Limb pH [Срок оценки: Recording will start immediately after placement of the probe and will continue intraoperatively and for 2 hours postoperatively]
Критерии участия
Критерии включения
- Adult patients (18 years to 89 years) undergoing surgical ankle fracture fixation at OHSU
Критерии исключения
- sepsis
- other significant long bone or internal injuries (including ipsilateral limb injuries).
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
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Oregon Health and Science University — Portland
Публикации
- Omeroglu H, Gunel U, Bicimoglu A, Tabak AY, Ucaner A, Guney O. The relationship between the use of tourniquet and the intensity of postoperative pain in surgically treated malleolar fractures. Foot Ankle Int. 1997 Dec;18(12):798-802. doi: 10.1177/107110079701801208. PMID 9429882
- Konrad G, Markmiller M, Lenich A, Mayr E, Ruter A. Tourniquets may increase postoperative swelling and pain after internal fixation of ankle fractures. Clin Orthop Relat Res. 2005 Apr;(433):189-94. doi: 10.1097/01.blo.0000151849.37260.0a. PMID 15805957
- Younger AS, Kalla TP, McEwen JA, Inkpen K. Survey of tourniquet use in orthopaedic foot and ankle surgery. Foot Ankle Int. 2005 Mar;26(3):208-17. doi: 10.1177/107110070502600305. PMID 15766423
- Hung M, Baumhauer JF, Licari FW, Voss MW, Bounsanga J, Saltzman CL. PROMIS and FAAM Minimal Clinically Important Differences in Foot and Ankle Orthopedics. Foot Ankle Int. 2019 Jan;40(1):65-73. doi: 10.1177/1071100718800304. Epub 2018 Oct 4. PMID 30282469
- Wilgis EF. Observations on the effects of tourniquet ischemia. J Bone Joint Surg Am. 1971 Oct;53(7):1343-6. No abstract available. PMID 5114697
- Cushing H. Pneumatic tourniquets: with especial reference to their use in craniotomies: Medical news; 1904.
Идентификаторы
NCT: NCT05445960 · STUDY00022560