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

Not Applicable

Not yet recruiting

• Conditions: Chronic Postoperative Pain

• Registration Number: NCT07160595
• Lead Sponsor: Fondation Hôpital Saint-Joseph

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-29
• Study First Submitted QC: 2025-09-05
• Last Update Submitted: 2025-09-05
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Study Start: 2025-11-01
• Primary Completion: 2028-04
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2052

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Proportion of patients with chronic post-operative pain at 6 months.	6 months post-operative

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (16)

Hôpital Prive Claude Galien; 🇫🇷 Boussy-Saint-Antoine, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

Clinique Jules Verne; 🇫🇷 Nantes, France

Hôpital Privé du confluent Santé Atlantique; 🇫🇷 Nantes, France

AP-HP : Hôpital de la Pitié Salpêtrière; 🇫🇷 Paris, France

AP-HP : Hôpital Saint-Louis; 🇫🇷 Paris, France

Clinique Drouot Remusat; 🇫🇷 Paris, France

Clinique Geoffroy Saint Hilaire; 🇫🇷 Paris, France

Hôpital de la Croix Saint-Simon; 🇫🇷 Paris, France

Hôpital Paris Saint-Joseph; 🇫🇷 Paris, France

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