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

Fondation Hôpital Saint-Joseph

Status: Not yet enrolling

Conditions: Chronic Postoperative Pain

Treatments: Other: Early management of postoperative pain at 3 months detected using sms

Study type: Interventional

Funder types: Other

Identifiers

NCT07160595

731_DROPS

ID RCB (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 2,052 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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2,052 participants in 2 patient groups

Control period 'without early intervention at 3 months'

No Intervention group

Description:

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'

Experimental group

Description:

During this period, patients with persistent post-operative pain, identified through SMS screening, will receive early treatment starting at 3 months.

Treatment:

Other: Early management of postoperative pain at 3 months detected using sms