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

NCT07160595 | Not Yet Recruiting

• 2 other identifiers: 731_DROPSID RCB
• Study Type: interventional
• Target: 2,052
• Locations: 1 country
• Sites: 16

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

Conditions

Chronic Postoperative Pain

Outcome Measures

Primary Outcomes (1)

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

  6 months post-operative

Secondary Outcomes (4)

• 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

Study Arms (2)

Control period 'without early intervention at 3 months'

NO INTERVENTION

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

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

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

Interventions

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.

Intervention period 'with early intervention at 3 months'

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (16)

Hôpital Prive Claude Galien

Boussy-Saint-Antoine, France

Location

Hospices Civils de Lyon

Lyon, France

Location

Clinique Jules Verne

Nantes, France

Location

Hôpital Privé du confluent Santé Atlantique

Nantes, France

Location

AP-HP : Hôpital de la Pitié Salpêtrière

Paris, France

Location

AP-HP : Hôpital Saint-Louis

Paris, France

Location

Clinique Drouot Remusat

Paris, France

Location

Clinique Geoffroy Saint Hilaire

Paris, France

Location

Hôpital de la Croix Saint-Simon

Paris, France

Location

Hôpital Paris Saint-Joseph

Paris, France

Location

Institut Curie : Hôpital de Paris

Paris, France

Location

Institut Mutualiste Montsouris

Paris, France

Location

Institut Curie : Hôpital de Saint Cloud

Saint-Cloud, France

Location

CHU de Saint-Etienne

Saint-Etienne, France

Location

Hôpital Foch

Suresnes, France

Location

CHU de Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Frédéric ADAM, Doctor of Medicine

CONTACT

01 44 12 36 18; fadam@ghpsj.fr

Célia MAMMA

CONTACT

01 44 12 32 54; cmamma@ghpsj.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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."

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (16)