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临床试验/NCT01467102
NCT01467102已完成不适用

euCPSP: European Observational Study on Chronic Post Surgical Pain,PAIN-OUT

European Society of Anaesthesiology24 个研究点 分布在 11 个国家目标入组 3,618 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,618
试验地点
24
主要终点
The incidence of chronic post surgical pain (CPSP)12 months after surgery

研究概览

简要总结

This project a European observational study on the incidence and characteristics of chronic post surgical pain (CPSP).

Research Questions

  • What is the incidence of chronic post surgical pain (CPSP) in Europe?
  • What are the risk factors of chronic post surgical pain (CPSP) related to surgery, patient and anaesthesia management?
  • What are the difference in incidence and risk factors in different European countries?

详细描述

The main goal of the study is to obtain a generalizable epidemiology of chronic post surgical pain (CPSP) by performing a large data collection in many European countries. The large sample will allow analysis of the incidence of CPSP, differences in incidence patterns in Europe, incidence in rare types of surgeries and specific populations. This observational, prospective study will help to better anticipate and potentially prevent the development of chronic post surgical pain (CPSP). In fact when CPSP occurs patients are frequently undiagnosed and pain is poorly managed such that patients may develop refractory chronic pain. Surgery is a major cause of chronic pain and it is unique in that there is potential to prevent it from occurring. Data from this study might alert respectively surgeons and anesthetists about the most important types of surgery and some perioperative techniques of pain prevention with an impact on the incidence of chronic post surgical pain(CPSP). Anesthesiologists, who are leading this project, might therefore, have an important role in preventing future cases of chronic post surgical pain (CPSP).

Sample size calculation:

The investigators expect that at least 30 sites will be able to participate and recruit 200 patients a year, to a maximum of 6,000 patients, over the one year study period. Since the mean incidence of CPSP is approximately 30%, this will offer an estimated potential number of 2000 patients with CPSP.

Organisation:

Investigators will use questionnaire in English, German, French, Spanish, Italian, Romanian, Swedish, Hebrew, Dutch and Russian. They will supervise data collection, ensure timely data return and act as guarantor for the integrity and quality of data collected.

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

  • Patient 18 years old and above
  • Patient has given consent
  • Patient is able to fill in questionnaire on his\her own, unaided (exceptions are patients who are unable to fill in the questionnaire for technical reasons, e.g. can not write due to the surgery (e.g. their arm in a cast) or unable to see the text (e.g. spectacles not available); patient is in department, available for interview.
  • Patient is capable of participating in the CPSP incidence study (i.e. capable to fill the questionnaires on the website at 6 and 12 months after surgery).
  • Time of data collection immediately after surgery is POD1 and 24±12 hrs after surgery.
  • Patient has not undergone repeat surgery (same organ) during current hospitalization.
  • Patient has undergone a surgery included in the appendix 1 list below:
  • List of surgeries to be included:
  • Surgery without preoperative pain
  • Thoracotomy for lung cancer
  • Breast surgery for cancer
  • Inguinal hernia repair (laparoscopic)
  • Hysterectomy (laparoscopic)
  • Hysterectomy (open)
  • Hysterectomy (vaginal)
  • Colectomy (laparoscopic)
  • Colectomy (open)
  • Thyroidectomy
  • High gastric bypass
  • Laparoscopy
  • Prostatectomy
  • Surgery with potential preoperative pain
  • Cholecystectomy (laparoscopic)
  • Cholecystectomy (open)
  • Total knee arthroplasty
  • Knee arthroscopy
  • Total hip arthroplasty
  • Extracorporeal circulation auxiliary to open heart surgery
  • Spinal surgery
  • Hip arthrotomy

排除标准

  • patient not fulfilling at least one of the inclusion criteria mentioned above

结局指标

主要结局

The incidence of chronic post surgical pain (CPSP)12 months after surgery

时间窗: 12 months

All patients will be asked to fill the Brief Pain Inventory (BPI) and questionnaires, at 12 months after surgery. They will do it directly on a dedicated website.

次要结局

  • Incidence of chronic post surgical pain (CPSP) 6 months after surgery(6 months)
  • risk factors of chronic post surgical pain (CPSP) related to the patient, surgery, anaesthesia and analgesia(12 months)

研究者

发起方
European Society of Anaesthesiology
申办方类型
Other
责任方
Sponsor

研究点 (24)

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