跳至主要内容
临床试验/NCT05739747
NCT05739747招募中不适用

Validation of the Gendolcat Score for the Prognosis of Chronic Postoperative Pain in Cesarean Section.

Consorci Sanitari de Terrassa1 个研究点 分布在 1 个国家目标入组 371 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
371
试验地点
1
主要终点
Short Edition of the Brief Pain Inventory

研究概览

简要总结

Chronic post-surgical pain is a problem that has historically been underestimated. Over the last few years there has been a search for strategies to both predict and prevent its occurrence in patients undergoing surgery. The Gendolcat index is the only predictive model that uses only objective pre-surgical variables to assess the risk of suffering chronic post-surgical pain. However, it is only validated for the following surgeries: thoracotomy, hysterectomy and open inguinal hernia. Our aim is to test whether the Gendolcat model is also valid for cesarean section.

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
Female
接受健康志愿者
否

入选标准

  • •Patients who underwent elective caesarean section.
  • •Patients who have previously signed the informed consent form.
  • •Exclusion Criteria
  • •Urgent cesarean section.
  • •Patients with severe psychiatric pathology.
  • •Patients who require a different surgical approach than usual.
  • •Patients who refuse to take part in the study and/or to sign the informed consent form.
  • •informed consent.
  • •Patients with a high language barrier.

排除标准

  • 未提供

结局指标

主要结局

Short Edition of the Brief Pain Inventory

时间窗: Done during physical examination will be performed 3 months after cesarean section.

Rapidly assesses the severity of pain and its impact on functioning

Numeric Pain Scale

时间窗: Done during physical examination will be performed 3 months after cesarean section.

Patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity

DN4 Questionnaire

时间窗: Done during physical examination will be performed 3 months after cesarean section.

To estimate the probability of neuropathic pain

Gendolcat score

时间窗: The Gendolcat score will be assessed on the day patients are included in the study

The Gendolcat score assesses the likelihood of suffering chronic post-surgical pain

Categoric Pain Scale

时间窗: Done during physical examination will be performed 3 months after cesarean section.

These pain scales give people a simple way to rate their pain intensity using a verbal or visual descriptor of their pain.

次要结局

未报告次要终点

研究者

发起方
Consorci Sanitari de Terrassa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carles Espinos Ramírez

M.D.

Consorci Sanitari de Terrassa

研究点 (1)

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