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Набор по приглашению NCT05315596

Longitudinal Assessment of Pain-Related Patient-Reported Outcomes After Surgery

— Наблюдательное Pain, Postoperative Adult Pain Measurement Functional Status

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: Pain, Postoperative, Adult, Pain Measurement, Functional Status. 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
Германия, Мексика
Следующий шаг
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Официальное название

Longitudinal Assessment of Pain-related Patient-reported Outcomes in the Sub-acute Phase After Surgery: a Registry Study From PAIN OUT

Обзор

Little is known about pain-related outcomes experienced by patients in the first few weeks after surgery, once they are discharged from hospital. This study aims to characterize pain, pain-related interference, and early neuropathic pain in the sub-acute phase after surgery.

Подробное описание

A high proportion of patients experience moderate to severe pain after surgery. However, most of the knowledge about this comes from studies where patients are evaluated in the hours and up until the first postoperative day. Alternatively, patients are assessed several months (eg 3 or later) after surgery, to evaluate the development of chronic pain related to surgery (CPSP) and most patients do not develop CPSP.

This study aims to learn how patients recover concerning pain and function once they return home after surgery. How long is it before they can resume their daily activities and to do so in comfort? Do they take treatment for pain? Do they have pain restricted to the surgical incision or it is more widespread? There is little knowledge as to whether there are signs of nerve injury in the days close to surgery. This type of pain might lead to chronic pain in later stages.

Patients will be assessed at three time points: the first day after surgery, the 7th day after surgery, and 1 month.

The information we obtain will offer healthcare providers, from multiple hospitals, information about the care they provide to their patients for pain while patients are still in hospital and insights as to how the care might be improved, once they are discharged.

Первичные конечные точки

  • The difference in pain interference scores between postoperative day 7 (POD7) and 1 month after surgery (POM1). [Срок оценки: 7th day after surgery (POD7) and 1 Month (M1) after surgery]
  • The number of patients with high pain interference on the 7th day after surgery (POD7). [Срок оценки: Day 7 after surgery]
Вторичные конечные точки (9)
  • Differences in pain severity (BPI-PSVS, pain severity scale) between postoperative day 7 and 1 month after surgery (POM1). [Срок оценки: Day 7 after surgery and Month 1 after surgery]
  • The differences in pain interference (BPI-PITS) between surgical disciplines on postoperative day 7. [Срок оценки: Day 7 after surgery]
  • The differences in pain interference (BPI-PITS) between surgical disciplines at month 1 after surgery. [Срок оценки: 1 Month after surgery]
  • The difference in the number of patients with signs of neuropathy on postoperative day 7 between the surgical disciplines. [Срок оценки: Day 7 after surgery]
  • The difference in the number of patients with signs of neuropathy at 1 month after surgery (POM1) between the surgical disciplines. [Срок оценки: 1 Month after surgery]
  • Differences in pain interference scores between patients with vs without signs of neuropathy on postoperative day 7 [Срок оценки: Day 7 after surgery]
  • Differences in pain interference (BPI-PITS) between patients with vs. without signs of neuropathy (DN2 score ≥ 3/7) at POM1. [Срок оценки: 1 Month after surgery]
  • Differences in pain severity between patients with vs without signs of neuropathy at POM1 [Срок оценки: 1 Month after surgery]
  • Assess the difference in the number of patients taking analgesics o POD7 vs POD1. [Срок оценки: Day 7 after surgery and 1 Month after surgery]

Критерии участия

Критерии включения

  • Adult
  • On the first post-operative day and back on the ward for at least 6 hours
  • Gives consent for assessment at 3-time points

Критерии исключения

  • The patient is unable to communicate
  • The patient is cognitively impaired
  • The patient is asleep
  • The patient is too ill or in too much pain and does not wish to be interviewed
  • The patient does not wish to fill in the outcomes questionnaire

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Мексика · 15 центров
  • Hospital General de Chihuahua Salvador Zubirán Anchondo — El Bajo
  • Hospital Aranda de La Parra (Leon Guanajuato) — León
  • Hospital Central Militar — Mexico City
  • Hospital San Javier Guadalajara — Guadalajara
  • Centro Nacional SIGLO XXI (IMSS) — Mexico City
  • Hospital Angeles Interlomas CDMX — Mexico City
  • Hospital de traumatologia y Ortopedia Lomas Verdes (IMSS) — Mexico City
  • Hospital fundación Medica Sur — Mexico City
  • … и ещё 7 центров
Германия · 1 центр
  • Jena University Hospital — Jena

Идентификаторы

NCT: NCT05315596 · JenaUH_pain

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗