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临床试验/NCT00812734
NCT00812734已完成不适用

Etude épidémiologique Multicentrique Des Douleurs Neuropathiques Post-opératoires

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 3,322 人开始时间: 2006年4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
3,322
试验地点
1
主要终点
Rate of persistent pain at 3 and 6 months after surgery

研究概览

简要总结

This cohort study aims to know the prevalence at 3 and 6 months after surgery, of persistent pain, as well as to describe the neuropathic features of this pain. It includes more than 3000 patients scheduled for different types of surgery, some of them already known to induce persistent pain, some being frequent procedures with no additional data. Clinical and genetical risk factors will be searched.

详细描述

Neuropathic post-surgical pain (NPSP) motivates the consultation of the French Centres for Evaluation and Treatment of Pain in 20 to 35% of the cases. The following table shows the available data of literature about chronic post-surgical pain:

Surgery Prevalence of chronic pain (%) Neuropathic symptoms Mastectomy 22 to 49 Yes Inguinal hernia repair 30 to 63 Yes Sternotomy 28 to 40 Unknown Saphenectomy 5 to 7 Yes Mandibular osteotomy Unknown Yes Cholecystectomy 3 to 20 Unknown Caesarean section 6 Unknown Thoracotomy 50 to 75 Yes Knee arthroscopy Unknown Unknown Rectal amputation 12 to 18 Unknown Limb amputation 60 Yes Endodontic treatment 5 to 13 Unknown

In most of these cases, the mechanism of pain is highly suspected as neuropathic, although the location of the nerve(s) concerned is unclear. However, the clinical features of the pain are often poorly described. In other types of surgery (such as caesarean section or cholecystectomy), the report of chronic pain may be related to the high frequency of these procedures.

The initiation of NPSP can be identified on a time scale (i.e. day of surgery), and can be prospectively expected. This leads to possibility of (i) a better understanding of the evolution of neuropathy following time and (ii) a study of putative preventive (peritraumatic) treatments. Thus, NPSP appears as strongly different from other chronic pain syndromes (such as diabetes mellitus, chemotherapy for cancer or even post-traumatic) for which the time course, mechanisms and psychic interactions are more complex.

We suspect that overall prevalence of NPSP may have been underestimated, as (i) the delay of onset of pain may be in a range between some days to several months, (ii) there is not always a systematic follow-up after most of the surgical procedures, and patients may stay out of the medical network and (iii) the benefit provided by the surgical procedure may lead to patient not to complain from a somewhat "necessary" complication.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

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

  • Agreement to the study
  • Scheduled for one of the following surgeries :
  • caesarean section
  • inguinal hernia repair
  • mastectomy
  • cholecystectomy under laparoscopy
  • saphenectomy (excluding harvesting for coronary bypass)
  • sternotomy
  • thoracotomy
  • knee arthroscopy
  • Major over 18 years

排除标准

  • Emergency
  • Inability to fill questionnaires
  • Unreachable patients

结局指标

主要结局

Rate of persistent pain at 3 and 6 months after surgery

时间窗: at 3 and 6 months after surgery

次要结局

  • Rate of persistent neuropathic pain at 3 and 6 months after surgery. Identification of risk factors collected before surgery. Links with genome.(at 3 and 6 months after surgery)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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