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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

2052 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2028-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Each center will be randomized into one of two sequences: "control period followed by intervention period" or "intervention period followed by control period."

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Control period 'without early intervention at 3 months'

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention period 'with early intervention at 3 months'

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

Group Type EXPERIMENTAL

Early management of postoperative pain at 3 months detected using sms

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No