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Идёт набор NCT06466941

Understanding the Acute Pain Phenotype in Patients Undergoing Surgery

— Наблюдательное Acute Pain Chronic Post Operative Pain Opioid Use

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: regional anesthesia, no regional anesthesia, acute pain consultation, no acute pain consultation.
Кому может быть актуально
Состояния в реестре: Acute Pain, Chronic Post Operative Pain, Opioid Use. 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

Impact of Patient Phenotypic Features on the Experience and Effectiveness of Regional Anesthesia and Postoperative Pain

Обзор

The goal of this observational study is to learn about how regional anesthesia (numbing medication) affects pain in patients with different psychosocial phenotypes such as different levels of concern about pain, sleep issues, and anxiety, who are having surgery. The main questions are: 1. Do psychosocial factors such as concerns about pain, sleep, anxiety affect the effectiveness of regional anesthesia? 2. Do psychosocial factors and regional anesthesia affect the amount of opioids used after surgery? 3. Do psychosocial factors and regional anesthesia affect development of chronic postsurgical pain?

Подробное описание

A patient's psychological profile importantly modulates pain severity, and the overall experience and impact of pain. For instance, catastrophic thinking about pain, including magnification, rumination, and helplessness, is associated with both greater pain severity and impact.

Over the years, regional anesthesia has become an integral part of multimodal pain management for many surgeries. Regional anesthesia (epidural and peripheral nerve blocks) to be associated with superior pain control, reduced time to return of bowel function, shorter intraoperative times, fewer side effects and complications, earlier ambulation and functional exercise capacity post-discharge, lower in-hospital mortality, reduced length-of-stay, improved patient satisfaction, and fewer readmissions.

The investigators aim to use of validated psychosocial surveys and semi-structured interviews to understand the phenotype of patients who will benefit the most from regional anesthesia. The investigators also aim to understand how different patient phenotypes and regional anesthesia affect perioperative opioid consumption, and development of chronic postsurgical pain.

Вмешательства

  • Процедура regional anesthesia
    Patients who underwent surgery and received an epidural or peripheral nerve block
  • Процедура no regional anesthesia
    Patients who underwent surgery and did not received an epidural or peripheral nerve block
  • Другое acute pain consultation
    Patients who underwent surgery and had a perioperative (preop, intraop, or postop) acute pain consultation
  • Другое no acute pain consultation
    Patients who underwent surgery and did not have a perioperative (preop, intraop, or postop) acute pain consultation

Первичные конечные точки

  • Maximum pain score over the first 24 hours after surgery [Срок оценки: 0-24 hours]
Вторичные конечные точки (5)
  • Worst pain score over the first 24 hours after surgery [Срок оценки: 0-24 hours]
  • Average pain score over the first 24 hours after surgery [Срок оценки: 0-24 hours]
  • Least pain score over the first 24 hours after surgery [Срок оценки: 0-24 hours]
  • Daily pain scores [Срок оценки: 0-7days]
  • Postoperative opioid consumption [Срок оценки: 0-7 days]

Критерии участия

Критерии включения

  • Age ≥ 18
  • English speaking
  • Surgical or procedural patient who will be admitted postoperatively
  • Willingness to answer psychosocial survey and/or audio recorded semi-structured interview

Критерии исключения

-Cognitive dysfunction that precludes communication

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Brigham and Women's Hospital — Boston

Публикации

  • Chen YK, Boden KA, Schreiber KL. The role of regional anaesthesia and multimodal analgesia in the prevention of chronic postoperative pain: a narrative review. Anaesthesia. 2021 Jan;76 Suppl 1(Suppl 1):8-17. doi: 10.1111/anae.15256. PMID 33426669
  • Schreiber KL, Zinboonyahgoon N, Flowers KM, Hruschak V, Fields KG, Patton ME, Schwartz E, Azizoddin D, Soens M, King T, Partridge A, Pusic A, Golshan M, Edwards RR. Prediction of Persistent Pain Severity and Impact 12 Months After Breast Surgery Using Comprehensive Preoperative Assessment of Biopsychosocial Pain Modulators. Ann Surg Oncol. 2021 Sep;28(9):5015-5038. doi: 10.1245/s10434-020-09479-2. PMID 33452600
  • Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X. PMID 16698416

Идентификаторы

NCT: NCT06466941 · 2023P003642

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗