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临床试验/NCT06704490
NCT06704490招募中不适用

Analysis of the Incidence and Risk Factors of Chronic Pain After Cesarean Section

Huazhong University of Science and Technology1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2024年2月1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
600
试验地点
1
主要终点
Incidence of chronic pain after caesarean section

研究概览

简要总结

Persistent postoperative pain is a globally recognized issue that deserves attention. Cesarean section is one of the surgeries that may cause persistent postoperative pain. PSPP may affect communication between mother and baby, and may lead to postpartum depression, which has a negative impact on the daily activities and quality of life of mothers. It is an important clinical issue.

The main purpose of this study is to (1) prospectively investigate the overall incidence and characteristics of persistent pain after cesarean section at 3, 6, and 12 months after surgery; (2) Use regression analysis and data modeling analysis to evaluate the relationship between perioperative variables and chronic pain in postpartum women undergoing cesarean section; (3) Analyze the relationship between chronic pain after cesarean section and postpartum depression in postpartum women.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age range from 20 to 50 years old;
  • ASA grades I to III;
  • Full term pregnancy and planned cesarean section with transverse incision in the lower segment of the uterus;
  • Pregnant women who are willing to participate in this study and sign informed consent forms.

排除标准

  • Have a history of dementia, mental illness, or any central nervous system disorder;
  • Pregnant women who are addicted to alcohol and drugs;
  • Difficulty in follow-up or poor patient compliance;
  • Has taken other investigational drugs or participated in other clinical trials in the three months prior to being selected for the study;
  • Serious complications occur during delivery;
  • Unable to cooperate with the research for any reason.

结局指标

主要结局

Incidence of chronic pain after caesarean section

时间窗: 2024-01-01-2025-01-01

Assessment of chronic postoperative pain by Brief Pain Inventory from 0 to ten, The higher the score, the stronger the pain

次要结局

  • Identification of high-risk factors for postoperative inadequate analgesia and PONV in obstetric patients based on machine learning methods(2024-2026)
  • Adverse effects of postoperative analgesia(2024-2026)
  • Checklist for Chronic pain after cesarean section(2024-2026)

研究者

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

Xianwei Zhang,MD

Professor

Huazhong University of Science and Technology

研究点 (1)

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