[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659760":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":20,"studyPopulation":20,"armGroups":30,"interventions":43,"overallOfficials":20,"centralContacts":51,"locations":57,"responsibleParty":136,"collaborators":20,"id":138,"slug":139,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":140,"sex":145,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":20,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":20,"overallStatus":157,"whyStopped":20,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},{"fullName":5,"class":6},"Nantes University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Chronic post-surgical pain","Chronic post-surgical pain is defined as pain with an intensity of ≥ 4 on a Simple Numerical Scale 6 months after surgery.","6 months",[14,18],{"measure":15,"description":16,"timeFrame":17},"effectiveness of the intervention","The effectiveness of the intervention will be assessed using:\n\n* The Brief Pain Inventory (BPI) at 3 months after randomisation\n* Intake of paracetamol, non-steroidal anti-inflammatory drugs, nefopam, tramadol, oral morphine, tricyclic antidepressants, serotonin and noradrenaline reuptake inhibitors (duloxetine, venlafaxine) and gabapentinoids (gabalin, pre-gabalin) in the Post-Interventional Monitoring Unit, on discharge from hospital, and at 3 months (prescribed doses).\n* Quality of life: PROMIS-29 Health-Related Quality of Life Scale at 3 months","3 months",{"measure":15,"description":19,"timeFrame":12},"The effectiveness of the intervention will be assessed using:\n\n* The Brief Pain Inventory (BPI) at 6 months after randomisation\n* Intake of paracetamol, non-steroidal anti-inflammatory drugs, nefopam, tramadol, oral morphine, tricyclic antidepressants, serotonin and noradrenaline reuptake inhibitors (duloxetine, venlafaxine) and gabapentinoids (gabalin, pre-gabalin) in the Post-Interventional Monitoring Unit, on discharge from hospital, at 6 months (prescribed doses).\n* Quality of life: PROMIS-29 Health-Related Quality of Life Scale at 6 months",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":26,"maskingDescription":20,"whoMasked":27},"DOUBLE",[28,29],"PARTICIPANT","INVESTIGATOR",[31,37],{"label":32,"type":33,"description":34,"interventionNames":35},"Experimental : lidocaïne","EXPERIMENTAL","The investigator then administers a volume corresponding to a bolus of 1.5 mg\u002Fkg of lidocaine , and then starts an infusion of 1.5 mg\u002Fkg\u002Fh of lidocaine (based on the patient's theoretical ideal weight)",[36],"Drug: Lidocain",{"label":38,"type":39,"description":40,"interventionNames":41},"Placebo","PLACEBO_COMPARATOR","The investigator then administers a volume corresponding to a bolus of 1.5 mg\u002Fkg of placebo, and then starts an infusion of 1.5 mg\u002Fkg\u002Fh of placebo (based on the patient's theoretical ideal weight)",[42],"Drug: Placebo",[44,49],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":20},"DRUG","Lidocain","The investigator then administers a volume corresponding to a bolus of 1.5 mg\u002Fkg of lidocaine and then starts an infusion of 1.5 mg\u002Fkg\u002Fh of lidocaine (based on the patient's theoretical ideal weight)",[32],{"type":45,"name":38,"description":40,"armGroupLabels":50,"otherNames":20},[38],[52],{"name":53,"role":54,"phone":55,"phoneExt":20,"email":56},"Raphaël CINOTTI PhD","CONTACT","0240084731","raphael.cinotti@chu-nantes.fr",[58,74,86,98,110,123],{"facility":59,"status":20,"city":60,"state":20,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"CHU Angers","Angers","49933","France","FR",{"type":65,"coordinates":66},"Point",[67,68],-0.55202,47.47156,{"lat":68,"lon":67},[71],{"name":72,"role":54,"phone":20,"phoneExt":20,"email":73},"Lasocki SIGISMOND, PhD","sigismond@lasocki.com",{"facility":75,"status":20,"city":76,"state":20,"zip":20,"country":62,"countryCode":63,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"CHU Brest","Brest",{"type":65,"coordinates":78},[79,80],-4.48628,48.39029,{"lat":80,"lon":79},[83],{"name":84,"role":54,"phone":20,"phoneExt":20,"email":85},"Charlotte RAIMBAULT","charlotte.raimbault@chu-brest.fr",{"facility":87,"status":20,"city":88,"state":20,"zip":20,"country":62,"countryCode":63,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"CHD Vendée","La Roche-sur-Yon",{"type":65,"coordinates":90},[91,92],-1.42757,46.66974,{"lat":92,"lon":91},[95],{"name":96,"role":54,"phone":20,"phoneExt":20,"email":97},"Alexis DUCHALAIS","alexis.duchalais@chd-vendee.fr",{"facility":99,"status":20,"city":100,"state":20,"zip":101,"country":62,"countryCode":63,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Chu Nantes","Nantes","44093",{"type":65,"coordinates":103},[104,105],-1.55336,47.21725,{"lat":105,"lon":104},[108],{"name":109,"role":54,"phone":20,"phoneExt":20,"email":56},"Raphaël CINOTTI, PhD",{"facility":111,"status":20,"city":112,"state":20,"zip":113,"country":62,"countryCode":63,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"CHU Rennes","Rennes","35000",{"type":65,"coordinates":115},[116,117],-1.67431,48.11109,{"lat":117,"lon":116},[120],{"name":121,"role":54,"phone":20,"phoneExt":20,"email":122},"Hélène BELOEIL, PhD","helene.beloeil@chu-rennes.fr",{"facility":124,"status":20,"city":125,"state":20,"zip":126,"country":62,"countryCode":63,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"CHU Toulouse","Toulouse","31059",{"type":65,"coordinates":128},[129,130],1.44367,43.60426,{"lat":130,"lon":129},[133],{"name":134,"role":54,"phone":20,"phoneExt":20,"email":135},"Guillaume PORTA BONETE","porta-bonete.g@chu-toulouse.fr",{"type":137,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100659760","phase-3-evaluation-of-the-efficacy-of-intravenous-lidocaine-on-chronic-post-operative-pain-in-patients-requiring-emergency-abdominal-surgery-a-multicentre-randomised-controlled-double-blind-study-100659760",false,"NCT07869173","\"Evaluation of the Efficacy of Intravenous Lidocaine on Chronic Post-operative Pain in Patients Requiring Emergency Abdominal Surgery. A Multicentre, Randomised, Controlled, Double-blind Study.\"","LIDOC-POPEYE","Inclusion Criteria:\n\n* Patients aged over 18 and under 80\n* Emergency or semi-emergency abdominal surgery of the following types:\n\nUrological Gastrointestinal Gynaecological\n\n* Open or laparoscopic surgery\n* Estimated duration of surgery ≥ 60 minutes\n\nExclusion Criteria:\n\n* Use of a regional anaesthesia technique involving epidural analgesia\n* Surgery as part of a transplant procedure\n* High-degree atrioventricular block without a pacemaker, chronic treatment with class I antiarrhythmic drugs\n* Shock defined as a systolic blood pressure ≤ 90 mmHg on admission to the emergency operating theatre\n* Respiratory failure defined as a respiratory rate \\> 25 breaths per minute and\u002For a transcutaneous oxygen saturation \\\u003C 90% on admission to the emergency operating theatre\n* Neurological impairment defined as a Glasgow Coma Scale score ≤ 13 on admission to the emergency operating theatre\n* Known dementia\n* Patients who are active drug users or undergoing withdrawal, given the significant difficulties in managing perioperative analgesia in these patients \\[65\\]\n* Pregnancy or breastfeeding. Women of childbearing age will undergo a pregnancy test prior to inclusion.\n* Porphyria\n* Contrai indications to lidocaine:","ALL","18 Years","80 Years",{"count":149,"type":150},266,"ESTIMATED","INTERVENTIONAL",[153],"PHASE3","Chronic pain is a major public health issue. According to the most recent sources, it affects around 11 million people in France, leading to a significant deterioration in patients' quality of life, limitations in their activities of daily living, and an impact on their mental health (anxiety and depression symptoms). Furthermore, chronic pain imposes a significant economic cost on society.\n\nIn France, it is estimated that 10 million surgical or interventional procedures are carried out each year. However, the most recent epidemiological data suggest that 20 to 30 per cent of patients will experience chronic post-surgical pain (CPSP) within 3 to 6 months following the procedure. It is therefore essential to improve perioperative care in order to reduce patients' CSPS: this would bring major benefits at both the individual and societal levels. Lidocaine is a local anaesthetic that has been widely used in human clinical practice for decades in the management of acute pain. Evidence also suggests that its use as a continuous intravenous infusion may have a beneficial effect on post-operative pain and reduce its incidence, but there are no guidelines regarding the use of lidocaine in this context. It therefore seems necessary to evaluate the efficacy of intravenous lidocaine on post-operative pain.\n\nThe Investigators propose to evaluate the efficacy of intravenous lidocaine on post-operative pain in a large-scale, multicentre, randomised, placebo-controlled trial (266 patients) involving patients requiring emergency abdominal surgery, a population at high risk of post-operative pain that has been little studied in the literature. In this study, we will assess the impact of post-operative pain on patients' quality of life and mental health.",[156],"Chronic Pain","NOT_YET_RECRUITING","2026-10-06",{"date":160,"type":161},"2026-10-09","ACTUAL",{"date":163,"type":150},"2027-01-15",{"date":165,"type":150},"2029-07-15",{"name":5,"class":6},6]