Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2025-12-29 @ 1:20 PM
Study NCT ID:
NCT07160595
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Benefit on Chronic Pain of Early Screening and Management of Patients With Persistent Postoperative Pain at 3 Months
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This study is a cluster crossover randomized trial. All participating centers (n=16) will take part in two sequential study periods:\n\n* 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.\n* 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.\n\nEach center will be randomized into one of two sequences: "control period followed by intervention period" or "intervention period followed by control period."'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2052}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2025-08-29', 'studyFirstSubmitQcDate': '2025-09-05', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with chronic post-operative pain at 6 months.', 'timeFrame': '6 months post-operative'}], 'secondaryOutcomes': [{'measure': 'Types of chronic post-operative pain at 3 and 6 months: frequency of neuropathic pain and pain due to excessive nociception', 'timeFrame': '3 and 6 months post-operative'}, {'measure': 'Proportion of patients responding to SMS during the various assessments', 'timeFrame': '3 and 6 months post-operative'}, {'measure': 'Sensitivity and specificity of SMS for diagnosing pain with neuropathic characteristics post-operatively at 3 and 6 months', 'timeFrame': '3 and 6 month post-operative'}, {'measure': 'Proportion of patients with pain at 3 and 6 months according to the type of surgery', 'timeFrame': '3 and 6 months post-operative'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Postoperative Pain']}, 'descriptionModule': {'briefSummary': '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.\n\nImproving 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.\n\nStudy design\n\nThis study is a cluster crossover randomized trial. All participating centers (n=16) will take part in two sequential study periods:\n\n* 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.\n* 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.\n\nStudy Population\n\nThe study will include patients undergoing the following minor surgical procedures:\n\n* Inguinal hernia repair\n* Breast reduction\n* Mastectomy with lymph node dissection\n* Knee arthroscopy\n* Knee ligament reconstruction\n\nStudy Schedule Recruitment Period: 24 months Patient Follow-up: 6 months Total Estimated Study Duration: 30 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have undergone one of the following procedures:\n\n * Inguinal hernia repair, regardless of the surgical technique used\n * Breast reduction\n * Mastectomy with or without reconstruction but with lymph node dissection\n * Knee arthroscopy or knee ligamentoplasty\n\n * Patients with a smartphone\n * French-speaking patients\n * Patients affiliated with a social security\n * Patients who have given their free and informed verbal consent\n\nExclusion Criteria:\n\n* Patients with pain sensitivity defined by the presence of chronic pain, use of level 3 morphine analgesics, use of anxiolytics, gabapentinoids and/or antidepressants\n* Patients subject to legal protection measures\n* Patients deprived of their liberty\n* Pregnant, labouring or breastfeeding patients'}, 'identificationModule': {'nctId': 'NCT07160595', 'acronym': 'DROPS', 'briefTitle': 'Benefit on Chronic Pain of Early Screening and Management of Patients With Persistent Postoperative Pain at 3 Months', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Hôpital Saint-Joseph'}, 'officialTitle': 'Benefit on Chronic Pain of Early Screening and Management of Patients With Persistent Postoperative Pain at 3 Months', 'orgStudyIdInfo': {'id': '731_DROPS'}, 'secondaryIdInfos': [{'id': 'ID RCB', 'type': 'OTHER', 'domain': '2025-A01249-40'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': "Control period 'without early intervention at 3 months'", 'description': '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).'}, {'type': 'EXPERIMENTAL', 'label': "Intervention period 'with early intervention at 3 months'", 'description': 'During this period, patients with persistent post-operative pain, identified through SMS screening, will receive early treatment starting at 3 months.', 'interventionNames': ['Other: Early management of postoperative pain at 3 months detected using sms']}], 'interventions': [{'name': 'Early management of postoperative pain at 3 months detected using sms', 'type': 'OTHER', 'description': 'During this period, patients with persistent post-operative pain, identified through SMS screening, will receive early treatment starting at 3 months.', 'armGroupLabels': ["Intervention period 'with early intervention at 3 months'"]}]}, 'contactsLocationsModule': {'locations': [{'city': 'Boussy-Saint-Antoine', 'country': 'France', 'contacts': [{'name': 'Célia MAMMA', 'role': 'CONTACT', 'email': 'cmamma@ghpsj.fr', 'phone': '01 44 12 32 54'}, {'name': 'Olivier MAUPAIN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Prive Claude Galien', 'geoPoint': {'lat': 48.69101, 'lon': 2.5306}}, {'city': 'Lyon', 'country': 'France', 'contacts': [{'name': 'Célia MAMMA', 'role': 'CONTACT', 'email': 'cmamma@ghpsj.fr', 'phone': '01 44 12 32 54'}, {'name': 'Fréderic AUBRUN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Nantes', 'country': 'France', 'contacts': [{'name': 'Célia MAMMA', 'role': 'CONTACT', 'email': 'cmamma@ghpsj.fr', 'phone': '01 44 12 32 54'}, {'name': 'Sébastien CAMPARD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique Jules Verne', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nantes', 'country': 'France', 'contacts': [{'name': 'Célia MAMMA', 'role': 'CONTACT', 'email': 'cmamma@ghpsj.fr', 'phone': '01 44 12 32 54'}, {'name': 'Gwillerm PLEDEL', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Privé du confluent Santé Atlantique', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Célia MAMMA', 'role': 'CONTACT', 'email': 'cmamma@ghpsj.fr', 'phone': '01 44 12 32 54'}, {'name': 'Sophie DI-MARIA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AP-HP : Hôpital de la Pitié Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Célia MAMMA', 'role': 'CONTACT', 'email': 'cmamma@ghpsj.fr', 'phone': '01 44 12 32 54'}, {'name': 'Delphine CHERON-LEROY', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AP-HP : Hôpital Saint-Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Célia MAMMA', 'role': 'CONTACT', 'email': 'cmamma@ghpsj.fr', 'phone': '01 44 12 32 54'}, {'name': 'Cyril QUEMENEUR', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique Drouot Remusat', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Célia MAMMA', 'role': 'CONTACT', 'email': 'cmamma@ghpsj.fr', 'phone': '01 44 12 32 54'}, {'name': 'Dan Alexandru COSTIN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique Geoffroy Saint Hilaire', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Célia MAMMA', 'role': 'CONTACT', 'email': 'cmamma@ghpsj.fr', 'phone': '01 44 12 32 54'}, {'name': 'Jean Michel DEVYS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital de la Croix Saint-Simon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Célia MAMMA', 'role': 'CONTACT', 'email': 'cmamma@ghpsj.fr', 'phone': '01 44 12 32 54'}, {'name': 'Fréderic ADAM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Paris Saint-Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Célia MAMMA', 'role': 'CONTACT', 'email': 'cmamma@ghpsj.fr', 'phone': '01 44 12 32 54'}, {'name': 'Jane MURET', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Curie : Hôpital de Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Célia MAMMA', 'role': 'CONTACT', 'email': 'cmamma@ghpsj.fr', 'phone': '01 44 12 32 54'}, {'name': 'Marc BEAUSSIER', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Mutualiste Montsouris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Saint-Cloud', 'country': 'France', 'contacts': [{'name': 'Célia MAMMA', 'role': 'CONTACT', 'email': 'cmamma@ghpsj.fr', 'phone': '01 44 12 32 54'}, {'name': 'Aline ALBI', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Curie : Hôpital de Saint Cloud', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}, {'city': 'Saint-Etienne', 'country': 'France', 'contacts': [{'name': 'Célia MAMMA', 'role': 'CONTACT', 'email': 'cmamma@ghpsj.fr', 'phone': '01 44 12 32 54'}, {'name': 'David CHARIER', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Suresnes', 'country': 'France', 'contacts': [{'name': 'Célia MAMMA', 'role': 'CONTACT', 'email': 'cmamma@ghpsj.fr', 'phone': '01 44 12 32 54'}, {'name': 'Morgan LEGUEN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'city': 'Toulouse', 'country': 'France', 'contacts': [{'name': 'Célia MAMMA', 'role': 'CONTACT', 'email': 'cmamma@ghpsj.fr', 'phone': '01 44 12 32 54'}, {'name': 'Vincent MINVILLE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Frédéric ADAM, Doctor of Medicine', 'role': 'CONTACT', 'email': 'fadam@ghpsj.fr', 'phone': '01 44 12 36 18'}, {'name': 'Célia MAMMA', 'role': 'CONTACT', 'email': 'cmamma@ghpsj.fr', 'phone': '01 44 12 32 54'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Hôpital Saint-Joseph', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}