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NCT Number: NCT07160595

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Prive Claude Galien, Boussy-Saint-Antoine, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early management of postoperative pain at 3 months detected using sms

Other

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

Primary outcomes

  1. Proportion of patients with chronic post-operative pain at 6 months.

    Time frame: 6 months post-operative

Secondary outcomes

  1. Types of chronic post-operative pain at 3 and 6 months: frequency of neuropathic pain and pain due to excessive nociception

    Time frame: 3 and 6 months post-operative

  2. Proportion of patients responding to SMS during the various assessments

    Time frame: 3 and 6 months post-operative

  3. Sensitivity and specificity of SMS for diagnosing pain with neuropathic characteristics post-operatively at 3 and 6 months

    Time frame: 3 and 6 month post-operative

  4. Proportion of patients with pain at 3 and 6 months according to the type of surgery

    Time frame: 3 and 6 months post-operative

Study contacts

Contact information is provided by the study sponsor or research team.

Célia MAMMA

CONTACT

[email protected]

01 44 12 32 54

Frédéric ADAM, Doctor of Medicine

CONTACT

[email protected]

01 44 12 36 18

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Acronym: DROPS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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