Opioid-Free Pain Treatment in Trauma Patients
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: Opioid-free pain treatment.
- Кому может быть актуально
- Состояния в реестре: Femoral Neck Fractures, Intertrochanteric Fractures, Femoral Shaft Fracture, Distal Femur Fracture. Базовые параметры: от 18 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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Официальное название
Peri-operative Opioid-free Analgesic Protocol for Orthopedic Trauma Patients
Обзор
Analgesic drug study that will compare pain outcomes of opioid analgesia and opioid-free analgesia in post-operative orthopedic patients.
Подробное описание
This will be a single center randomized trial. The study will be conducted using block randomization, with two six-month blocks of patient enrollment. The first block will consist of patients undergoing treatment of the above-mentioned fractures with normal standard of care pain management protocol (pre-, intra-, and postoperatively). The second block will consist of patients undergoing treatment the same fractures with opioid-free pain management protocol (pre-, intra-, and postoperatively). Block selection will be determined based on the date of the surgery. However, patients initially assigned to the opioid-free protocol that have CKD/laboratory evidence of poor renal function (ie, elevated BUN/Creatinine) or laboratory evidence of liver function issues (ie, cirrhosis, hypoalbuminemia, elevated liver transaminases, elevated GGT) will crossover to the opioid group as NSAID use and acetaminophen use, respectively, are contraindicated. The use of block randomization will preclude the need for the study coordinator to perform any sort of individual randomization or sealed envelope use for treatment assignment. For subjects who meet eligibility criteria, study informed consent will be obtained at the same time as surgical consent. Patients in the standard of care study block will undergo KUMC's normal pain management strategy. Patients in the opioid-free study block will receive the same pain-management drugs as the opioid group aside from receiving opioids; all other medical care will be standard in this group. Postoperative weightbearing, immobilization, perioperative antibiotics, drain usage, and discharge criteria will be determined by institutional protocols and will remain the same for each block. All patients will be started on postoperative chemical anticoagulation prophylaxis as determined by their fracture pattern and medical comorbidities. Patients will be clinically monitored for signs of venous thromboembolism and appropriate diagnostic screening will be utilized as necessary. Wound complications will be monitored by the treating surgeon and managed as necessary. The study team also plans to record patient specific factors including age, sex, BMI, smoking status, comorbidities, and operative time. These variables will be analyzed independently to detect any correlation with the two pain management protocols.
Вмешательства
- Другое Opioid-free pain treatment
Pain treatment includes any medications up to the medical team's discretion aside from opioids.
Первичные конечные точки
- Numerical Rating Scale (NRS) Pain Scores [Срок оценки: From post surgery up until 6 months post surgery]
Вторичные конечные точки (3)
- Postoperative complications [Срок оценки: From post surgery up until 6 months post surgery]
- Medication usage (timing) [Срок оценки: From post surgery up until 6 months post surgery]
- Medication usage (quantity) [Срок оценки: From post surgery up until 6 months post surgery]
Критерии участия
Критерии включения
- Patient is over the age of 18 years old
- Underwent surgical treatment for the injuries of interest (stated elsewhere) by an Orthopedic Traumatology Attending Physician at the University of Kansas Hospital
Критерии исключения
- Patients that are unable to provide informed consent due to sustaining a head injury or incoherence from narcotics given to them post-injury
- Chronic opioid use
- Under the age of 18 years old
- Undergoing revision surgery
- Did not undergo surgical fixation
- Pregnant/nursing women
- Vulnerable populations as defined by the University of Kansas Medical Center IRB
- Did not experience one of the following fractures listed in D.1. above.
- Patients with CKD and/or cirrhosis will be excluded from the opioid-free pain block (block 2) and will only qualify for the standard of care opioid group (Block 1)
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
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 1 центр
- The University of Kansas Medical Center — Kansas City
Идентификаторы
NCT: NCT06078371 · STUDY00149431