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临床试验/NCT05865366
NCT05865366已完成不适用

Pain Trajectories and Predictors After Noncardiac Surgery in Elderly Patients: a Prospective and Observational Cohort Study

Feng Gao1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
Acute pain trajectories after surgery

研究概览

简要总结

This study will use group-based trajectory modeling to identify the different postoperative pain trajectory groups that exist in a mixed surgical population (non-cardiac surgery) of elderly patients during the first seven days after surgery. The aim of this study is to explore the diversity in the development of postoperative pain among elderly patients and to identify the risk factors for acute pain trajectory after surgery by investigating demographic, psychological, and clinical variables. The predictive effect of different trajectories of early postoperative acute pain on postoperative chronic pain will also be explored.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled for thoracic, urologic, gastrointestinal, gynecological, liver, biliary/pancreatic, or major orthopedic surgery under general anesthesia
  • Age ≥ 65 years
  • The American Society of Anaesthesiologists(ASA) I to III
  • Duration of hospitalization ≥ 72 hours

排除标准

  • Language disorder;
  • Hearing impairment;
  • Visual impairment;
  • The expected postoperative intubation time is more than 24 hours;
  • Critical events occurred during the perioperative period.

结局指标

主要结局

Acute pain trajectories after surgery

时间窗: Seven days after surgery.

The acute pain trajectories are vectors of 7 numerical pain scores (ranging from 0 ,which indicates "no pain," to 10 , which indicates "pain as bad as you can imagine") taken over 7 days (days 1, 2, 3, 4, 5, 6, 7).

Presence of pain 6 months after surgery assessed using the Brief Pain Inventory.

时间窗: 6 months after surgery

Yes/No

Presence of pain 3 months after surgery assessed using the Brief Pain Inventory.

时间窗: 3 months after surgery

Yes/No

次要结局

  • The anxiety score assessed using Amsterdam preoperative anxiety and information scale(day1 before surgery)
  • consumption of analgesic drugs(Seven days after surgery)
  • The douleur neuropathique 4 questionnaire(DN4)(day1 before surgery)
  • Mini-cog(day1 before surgery)
  • Geriatrie depression scale,GDS-15(day1 before surgery)
  • cumulative illness rating scale for geriatrics,CIR S-G(day1 before surgery)
  • The FRAIL Scale(Fatigue, Resistance, Ambulation, Illness and Loss of Weight Index,FRAIL)(day1 before surgery)
  • Complications within 7 days after surgery(Seven days after surgery)
  • Presence of pain before surgery assessed using the Brief Pain Inventory.(day1 before surgery)

研究者

发起方
Feng Gao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Feng Gao

Professor

Tongji Hospital

研究点 (1)

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