Ransitional Teleconsultation to Prevent Chronic Postsurgical Pain in Chronic Opioid Users
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 354
- 试验地点
- 1
- 主要终点
- Incidence of chronic postsurgical pain (CPSP)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incidence of chronic postsurgical pain (CPSP)
时间窗: at 3 months
Incidence of chronic postsurgical pain (CPSP) at 3 months, defined as: * new or aggravated postsurgical pain located at the surgical site or innervated territory, * persistent for ≥3 months, * intensity ≥3/10 (new pain) or increase ≥2/10 from baseline (aggravation), * with significant functional impact (≥3/10 on at least one Brief Pain Inventory interference item), * assessed at day 90 ±14.
次要结局
- Pain trajectory(at 3 months)
- Pain trajectory(at 6 months)
- Opioid use(at 3 months)
- Opioid use(at 6 months)
- Descriptive medico-economic analysis(at 6 months)