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Идёт набор NCT05369130

Investigate and Predict Aortic & Thoracic Surgery Persistenet Postsurgical Pain

Наблюдательное Persistent Postsurgical Pain

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: Persistent Postsurgical Pain. 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
Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Characterising the Phenotype for Persistent Postoperative Pain Following Repair of the Thoraco-abdominal Aorta

Обзор

This is an observational clinical study aiming to further the wider understanding of patients who develop persistent pain after Thoracoabdominal Aorta surgery, a surgical cohort who are disproportionately affected. This will be undertaken through a prospective biopsychosocial characterisation of the phenotype of patients undergoing this operation. Increasing numbers of patients are undergoing surgery on the chest for treatment of heart or lung cancer disease. Over the last twenty years, the medical community has become increasingly aware of the long-term effect of this surgery in producing persistent pain, approximately half of all survivors are still in pain around their surgical incision at three months postoperatively and beyond. There is currently no accepted method for preventing this phenomenon. The nervous system mechanisms for the development of persistent pain after surgery are unclear. Some studies suggest it may involve the patient's ability to dampen down pain signals travelling from the incision site to the brain. Humans have an in-built system that produces opiates as well as other pain-relieving molecules in response to injury, e.g. surgery. However, this response varies hugely from person to person and may even be impacted by the psychological state of the individual at the time of surgery. Some of these pain modulating mechanisms can be measured before and after surgery in patients using sensory testing, a robust and established objective method to assess patients'. Identifying patients who are most at risk of a persistent pain state will allow both academics and clinicians to investigate and better target appropriate treatments. Undertaking these longitudinal observational assessments will facilitate an improved mechanistic insight of the transition from acute to pathological pain, with the ultimate goal of improving outcomes for patients'.

Первичные конечные точки

  • Characterise the sensory phenotype of Persistent Postsurgical Pain following Thoracoabdominal Aortic Surgery with Quantitative Sensory Testing as a change measure. [Срок оценки: 3 Years]
  • Characterise the Pain Intensity as a change measure following Thoracoabdominal Aortic Surgery [Срок оценки: 3 years]
  • Characterise the Pain Intensity as a change measure following Thoracoabdominal Aortic Surgery [Срок оценки: 3 years]
  • Characterise the analgesia requirements as a change measure following Thoracoabdominal Aortic Surgery [Срок оценки: 3 years]
  • Characterise the analgesia requirements as a change measure following Thoracoabdominal Aortic Surgery [Срок оценки: 3 years]
  • Characterise the presence of neuropathic sensory phenotype of patients undergoing Thoracoabdominal Aortic Surgery pre-op, post-op and > 3 months post-op. [Срок оценки: 3 years]
  • Characterise the presence of neuropathic sensory phenotype of patients undergoing Thoracoabdominal Aortic Surgery pre-op, post-op and > 3 months post-op. [Срок оценки: 3 years]
  • Characterise the change in biochemical phenotype pre-op and in the early post-op period following Thoracoabdominal Aortic Surgery and define significant differences between those with and without persistent post surgical pain [Срок оценки: 3 Years]
  • Characterise the change in biochemical phenotype pre-op and in the early post-op period following Thoracoabdominal Aortic Surgery and define significant differences between those with and without persistent post surgical pain [Срок оценки: 1 Week]
  • Identify Predictors of Persistent Postsurgical Pain following Thoracoabdominal Aorta surgery [Срок оценки: 3 years]
Вторичные конечные точки (4)
  • Determine the influence of baseline psychological and social profiles on postoperative pain outcomes. [Срок оценки: 3 years]
  • Determine the influence of baseline psychological and social profiles on postoperative pain outcomes. [Срок оценки: 3 years]
  • Determine the influence of baseline psychological and social profiles on postoperative pain outcomes. [Срок оценки: 3 years]
  • Describe the impact of Persistent Post Surgical Pain on Quality of Life [Срок оценки: 3 years]

Критерии участия

Критерии включения

  • Adults (over 18 years of age) undergoing elective repair of the thoraco-abdominal aorta. Able to adequately understand and respond to verbal instructions

Критерии исключения

  • Unwilling or unable to give consent, Age <18 years

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Великобритания · 1 центр
  • St Bartholomew's Hospital — London

Идентификаторы

NCT: NCT05369130 · 303825

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗