Benefit on Chronic Pain of Early Screening and Management of Patients With Persistent Postoperative Pain at 3 Months

Обзор

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

Вмешательства

• Другое Early management of postoperative pain at 3 months detected using sms
  During this period, patients with persistent post-operative pain, identified through SMS screening, will receive early treatment starting at 3 months.

Первичные конечные точки

• Proportion of patients with chronic post-operative pain at 6 months. [Срок оценки: 6 months post-operative]

Вторичные конечные точки (4)

• Types of chronic post-operative pain at 3 and 6 months: frequency of neuropathic pain and pain due to excessive nociception [Срок оценки: 3 and 6 months post-operative]
• Proportion of patients responding to SMS during the various assessments [Срок оценки: 3 and 6 months post-operative]
• Sensitivity and specificity of SMS for diagnosing pain with neuropathic characteristics post-operatively at 3 and 6 months [Срок оценки: 3 and 6 month post-operative]
• Proportion of patients with pain at 3 and 6 months according to the type of surgery [Срок оценки: 3 and 6 months post-operative]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Франция · 16 центров

• Hôpital Prive Claude Galien — Boussy-Saint-Antoine
• Hospices Civils de Lyon — Lyon
• Clinique Jules Verne — Nantes
• Hôpital Privé du confluent Santé Atlantique — Nantes
• AP-HP : Hôpital de la Pitié Salpêtrière — Paris
• AP-HP : Hôpital Saint-Louis — Paris
• Clinique Drouot Remusat — Paris
• Clinique Geoffroy Saint Hilaire — Paris
• … и ещё 8 центров

Идентификаторы

NCT: NCT07160595 · 731_DROPS · ID RCB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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