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临床试验/NCT04313855
NCT04313855已完成不适用

Help With Early Detection of Postoperative Neuropathic Pain Using SMS After Ambulatory Surgery

Fondation Hôpital Saint-Joseph2 个研究点 分布在 1 个国家目标入组 306 人开始时间: 2020年12月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
306
试验地点
2
主要终点
diagnostic method

研究概览

简要总结

Chronic post-operative pain is generally defined by persistent pain more than 2 months after surgery. General reviews on chronic post-operative pain describe an overall incidence of 30%, of which 5 to 10% are described as severe. Different risk factors have been identified: pain and preoperative opioid use, anxiety - depression, catastrophism, type of surgery, intensity and duration of postoperative pain, genetic factors.

If postoperative pain is essentially pain caused by excess nociceptive stimulation, investigators realize that a neuropathic component is far from being exceptional and that this can be demonstrated quickly after surgery. In addition, these neuropathic pains respond little or no to the usual analgesics and in particular to opioids, which can be the cause of misuse or death from overdose. Early detection of pain of a neuropathic nature would allow appropriate therapy to be put in place and may therefore reduce the risk of chronic postoperative pain.

The concept of ambulatory surgery assumes that postoperative pain will be minimal and can be controlled at home by the administration of oral pain relievers. However, following the development of surgical techniques and the improvement in the quality of care, the number and complexity of procedures that can be performed in ambulatory surgery have increased considerably. Consequently, a significant number of patients will probably develop chronic post-operative pain without the possibility of early detection. The prevalence of chronic post-operative pain in ambulatory surgery has been studied by a single team. The authors conclude that it is underestimated and variable depending on the surgery between 15 and 32%.

For the past few years, the GHPSJ has been using an ambulatory surgery algorithm that sends SMS messages to warn and follow up on patients. The principle is simple: patients scheduled for outpatient surgery receive text messages the day before their intervention to remind them of the instructions to be followed and the meeting times and, the day after the operation, the algorithm sends SMS to ask patients if all is well or if they have pain, nausea or vomiting, discharge from the scar. In postoperative monitoring, this technology has shown promising results.

This technology has not been used in the screening of persistent pain. The objective of this work is to assess the effectiveness of an SMS algorithm in the early detection of postoperative neuropathic pain after surgery performed on an outpatient basis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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 aged ≥ 18 years
  • Patient hospitalized on an outpatient basis within the Paris Saint Joseph Hospital Group in the following different surgical specialties: orthopedics, digestive, vascular, gynecological, plastic and restorative
  • French speaking patient
  • Patient with smartphone
  • Patient affiliated to a social security scheme
  • Patient having given oral, free, informed and express consent

排除标准

  • Patient under guardianship or curatorship
  • Patient deprived of liberty

结局指标

主要结局

diagnostic method

时间窗: Day 7

This outcome corresponds to the calculation of the sensitivity and the specificity of the diagnostic method tested which is the combination of SMS and the DN2 questionnaire.

次要结局

  • Persistent post-surgical pain day 90(Day 90)
  • Neuropathic pain day90(Day 90)
  • signs suggestive of neuropathic pain day90(Day 90)
  • Comparison of pain between day7 and day90(Day90)
  • Proportion of patients presenting signs suggestive of pain(Day90)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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