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ClinicalTrials.gov ID

NCT07160595

Lead Sponsor

Fondation Hôpital Saint-JosephOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

2,052Estimated

Last Update Posted

Sep 8, 2025Actual

Start Date

Nov 2025Estimated

Primary Completion Date

Apr 2028Estimated

Completion Date

Apr 2028Estimated

Official Title

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

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

• Chronic Postoperative Pain

• Early management of postoperative pain at 3 months detected using sms

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Screening

Allocation

Randomized

Interventional Model

Crossover Assignment

Masking

None (Open Label)

Lead Sponsor

Fondation Hôpital Saint-JosephOTHER

cmamma@ghpsj.fr01 44 12 32 54

cmamma@ghpsj.fr01 44 12 32 54

cmamma@ghpsj.fr01 44 12 32 54

cmamma@ghpsj.fr01 44 12 32 54

cmamma@ghpsj.fr01 44 12 32 54

cmamma@ghpsj.fr01 44 12 32 54

cmamma@ghpsj.fr01 44 12 32 54

cmamma@ghpsj.fr01 44 12 32 54

cmamma@ghpsj.fr01 44 12 32 54

cmamma@ghpsj.fr01 44 12 32 54

cmamma@ghpsj.fr01 44 12 32 54

cmamma@ghpsj.fr01 44 12 32 54

cmamma@ghpsj.fr01 44 12 32 54

cmamma@ghpsj.fr01 44 12 32 54

cmamma@ghpsj.fr01 44 12 32 54