Pain Predict Genetics
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Chronic Pain, Acute Pain. Базовые параметры: 18 лет — 80 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
- Нидерланды
- 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
Development of Postoperative Pain; Clinical and Genetic Factors
Обзор
Pain is the most frequent cause of suffering and disability in society. Despite considerable involvement of genetic factors in pain sensation and sensitivity, the individual genes involved remain largely unidentified. In this project the investigators will follow patients undergoing elective major surgery for the development of acute and chronic pain. The investigators will search for clinical as well as genetic factors that can predict the development of pain. These can serve as biomarkers to predict acute and chronic pain development and progression in individual patients and help early individual treatment adaptation.
Подробное описание
Pain is the most frequent cause of suffering and disability in society. Chronic pain seriously impairs quality of life of millions of people worldwide. 10-50% of surgical patients report chronic pain after surgery; up to 10% report severe pain. Thus, chronic pain is a significant medical and financial burden to society.
Despite considerable involvement of genetic factors in pain sensation and sensitivity, individual genes involved remain largely unidentified. Knowledge of genetic factors, their phenotypic expression in pain processing, and their link to neuronal correlates can improve understanding of pain aetiology and processes involved in pain perception and chronification. Also, they can serve as biomarkers to predict chronic pain development and progression in patients and help early individual treatment adaptation.
In this study the investigators will establish a prospective database and biobank of patients undergoing elective major surgery. Using data from the database and biobank, the investigators will identify genetic factors contributing to development of acute and chronic pain after surgery.
Over a period of 10 years the investigators will prospectively include up to 10,000 patients visiting the hospital for elective major surgery. Data defining participants demographics, medical history and questionnaire data will be collected and stored in dedicated databases. Additional details (surgery and perioperative management, pain processing phenotypes and surgical and pain outcomes) will be stored.
Первичные конечные точки
- Genetic risk factors for the development of acute pain using a visual analogue scale. [Срок оценки: 7 days]
- Genetic risk factors for the development of chronic pain (defined as pain (yes or no) for more than 3 months in one specific body area). [Срок оценки: 6 months]
Вторичные конечные точки (7)
- If the pain influences daily functioning will be assesed with the pain disability index. [Срок оценки: 6 months]
- Is fear before an operation related to the development of acute and chronic pain after the operation. [Срок оценки: once pre-operatively]
- Is the Pain Catastrophizing Scale related to the development of acute and chronic pain after the operation. [Срок оценки: once pre-operatively]
- Is Pain Sensitivity related to the development of acute and chronic pain after the operation. [Срок оценки: once pre-operatively]
- Is the size of the incision made during the operation associated with pain development. [Срок оценки: 6 months]
- Is days in hospital after the operation associated with pain development. [Срок оценки: 6 months]
- Is medication use after the operation assocaited with pain development. [Срок оценки: 6 months]
Критерии участия
Критерии включения
Patients:
- Ages 18 - 80 years, consenting, planned surgery, able to understand and answer questionnaires.
Критерии исключения
- Non-consent, inability to give consent, unplanned and emergency surgery.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Нидерланды · 1 центр
- Radboudumc — Nijmegen
Публикации
- Li S, van Boekel RLM, van den Heuvel SAS, Coenen MJH, Vissers KCP. Pain predict genetics: protocol for a prospective observational study of clinical and genetic factors to predict the development of postoperative pain. BMJ Open. 2022 Nov 29;12(11):e066134. doi: 10.1136/bmjopen-2022-066134. PMID 36446453
Идентификаторы
NCT: NCT02383342 · NL26908.091.12