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临床试验/NCT06466941
NCT06466941招募中不适用

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

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年7月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
2
主要终点
Maximum pain score over the first 24 hours after surgery

研究概览

简要总结

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?

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Cognitive dysfunction that precludes communication

结局指标

主要结局

Maximum pain score over the first 24 hours after surgery

时间窗: 0-24 hours

Maximum pain score (numerical pain rating score 0-10) over the first 24 hours after surgery

次要结局

  • Average pain score over the first 24 hours after surgery(0-24 hours)
  • Daily pain scores(0-7days)
  • Worst pain score over the first 24 hours after surgery(0-24 hours)
  • Least pain score over the first 24 hours after surgery(0-24 hours)
  • Longitudinal pain scores(1-12 months)
  • Postoperative opioid consumption(0-7 days)
  • Incidence of chronic postsurgical pain(3-12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Edwards

Pain Psychologist

Brigham and Women's Hospital

研究点 (2)

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