Benefit on Chronic Pain of Early Screening and Management of Patients With Persistent Postoperative Pain at 3 Months
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,052
- 试验地点
- 16
- 主要终点
- Proportion of patients with chronic post-operative pain at 6 months.
研究概览
简要总结
Chronic postoperative pain has an overall incidence of approximately 30%, with 5% to 10% of cases classified as severe (numerical rating scale > 6/10). However, its management remains suboptimal, primarily due to underdiagnosis and delayed referral of patients to specialized chronic pain centers.
Improving the screening of patients with chronic postoperative pain is therefore crucial. Our research has shown that early detection of postoperative neuropathic pain is possible using just two text messages (SMS), as early as three months after surgery. Early screening, combined with prompt management, can prevent pain from becoming chronic and mitigate its harmful effects.
Study design
This study is a cluster crossover randomized trial. All participating centers (n=16) will take part in two sequential study periods:
- Control Period: "Without early treatment at 3 months" During this period, patients with persistent postoperative pain-identified via SMS-will receive treatment at 6 months. This reflects the current standard of care for patients with postoperative pain.
- Intervention Period: "With early treatment at 3 months" During this period, patients with persistent postoperative pain-identified via SMS-will receive early treatment starting at 3 months.
Study Population
The study will include patients undergoing the following minor surgical procedures:
- Inguinal hernia repair
- Breast reduction
- Mastectomy with lymph node dissection
- Knee arthroscopy
- Knee ligament reconstruction
Study Schedule Recruitment Period: 24 months Patient Follow-up: 6 months Total Estimated Study Duration: 30 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 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
- •Patients who have undergone one of the following procedures:
- •Inguinal hernia repair, regardless of the surgical technique used
- •Breast reduction
- •Mastectomy with or without reconstruction but with lymph node dissection
- •Knee arthroscopy or knee ligamentoplasty
- •Patients with a smartphone
- •French-speaking patients
- •Patients affiliated with a social security
- •Patients who have given their free and informed verbal consent
排除标准
- •Patients with pain sensitivity defined by the presence of chronic pain, use of level 3 morphine analgesics, use of anxiolytics, gabapentinoids and/or antidepressants
- •Patients subject to legal protection measures
- •Patients deprived of their liberty
- •Pregnant, labouring or breastfeeding patients
研究组 & 干预措施
Control period 'without early intervention at 3 months'
During this period, patients with persistent post-operative pain, identified through SMS screening, will be treated at 6 months (this reflects the current standard experience for patients with postoperative pain).
Intervention period 'with early intervention at 3 months'
During this period, patients with persistent post-operative pain, identified through SMS screening, will receive early treatment starting at 3 months.
干预措施: Early management of postoperative pain at 3 months detected using sms (Other)
结局指标
主要结局
Proportion of patients with chronic post-operative pain at 6 months.
时间窗: 6 months post-operative
次要结局
- Types of chronic post-operative pain at 3 and 6 months: frequency of neuropathic pain and pain due to excessive nociception(3 and 6 months post-operative)
- Proportion of patients responding to SMS during the various assessments(3 and 6 months post-operative)
- Sensitivity and specificity of SMS for diagnosing pain with neuropathic characteristics post-operatively at 3 and 6 months(3 and 6 month post-operative)
- Proportion of patients with pain at 3 and 6 months according to the type of surgery(3 and 6 months post-operative)