Prevention of Chronic Postsurgical Pain in Chronic Opioid Users: (PRE-OPIOID)
Ransitional Teleconsultation to Prevent Chronic Postsurgical Pain in Chronic Opioid Users
Chronic opioid users undergoing surgery are at increased risk of CPSP, contributing to long-term disability, decreased quality of life, and prolonged opioid exposure. Existing preventive strategies remain limited, and early postoperative monitoring may represent a key opportunity for intervention. Evidence suggests that transitional pain services can improve outcomes by optimizing pain control and reducing long-term opioid consumption, but implementation is heterogeneous and often resource-intensive. Telemedicine offers a scalable alternative, enabling early specialized evaluation and timely therapeutic adjustments while maintaining accessibility. This randomized controlled trial will compare standard postoperative follow-up with standard follow-up plus a specialized teleconsultation performed between postoperative day 15 and 28. The intervention aims to detect insufficiently controlled pain, signs of neuropathic pain, or maladaptive opioid use, and to propose individualized therapeutic adjustments when required.
Participants will be followed for 6 months. Primary assessment will occur at 3 months to determine CPSP incidence. Secondary assessments will include pain trajectory (intensity, neuropathic features, functional interference), opioid consumption and misuse, quality of life, and a descriptive medico- economic evaluation
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Paul Tarpin, MD
- 电话号码:33+3.22.08.79.80
- 邮箱:Tarpin.paul@chu-amiens.fr
学习地点
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Amiens、法国、80054
- 招聘中
- CHU Amiens-Picardie
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接触:
- Paul TARPIN, MD
- 电话号码:0322087980
- 邮箱:Tarpin.Paul@chu-amiens.fr
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副研究员:
- Ottilie Fumery, MD
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age ≥18 years
- Elective non-urgent surgery with expected moderate or higher postoperative pain
- Chronic preoperative opioid use
- Written informed consent
- affiliated with a national social security scheme
Exclusion Criteria:
- Ambulatory surgery
- Endoscopic or palliative surgery
- Patients receiving opioid substitution therapy
- Non-medical opioid use
- Intrathecal/epidural analgesia or implanted neurostimulator
- Legally protected adults
- Severe psychiatric or neurodegenerative disorders
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Standard care + specialized postoperative teleconsultation
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standard institutional perioperative management
Patients in the intervention arm participate in a specialized teleconsultation between postoperative day 15-28 to detect poorly controlled pain, neuropathic features, or opioid-related concerns, and to adjust treatment if needed.
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有源比较器:Standard postoperative care alone
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standard institutional perioperative management
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of chronic postsurgical pain (CPSP)
大体时间:at 3 months
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Incidence of chronic postsurgical pain (CPSP) at 3 months, defined as:
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at 3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain trajectory
大体时间:at 3 months
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Pain trajectory is measured by using intensity (BPI), + neuropathic features (DN4) +Quality of life (EQ-5D-5L)
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at 3 months
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Pain trajectory
大体时间:at 6 months
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Pain trajectory is measured with intensity (BPI), neuropathic features (DN4), Quality of life (EQ-5D- 5L)
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at 6 months
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Opioid use
大体时间:at 3 months
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Opioid use is defined as oral morphine equivalent consumption, proportion with reduction/discontinuation, POMI-5F, SOWS, DSM-5 OUD criteria
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at 3 months
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Opioid use
大体时间:at 6 months
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Opioid use is defined as oral morphine equivalent consumption, proportion with reduction/discontinuation, POMI-5F, SOWS, DSM-5 OUD criteria
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at 6 months
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Descriptive medico-economic analysis
大体时间:at 6 months
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Descriptive medico-economic analysis is determined with assessment of direct and indirect costs, descriptive comparison of effectiveness (incidence of CPSP at 6 months),descriptive reporting of utility values derived from EQ-5D-5L at 6 months
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at 6 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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