[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598834":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":46,"locations":53,"responsibleParty":67,"collaborators":69,"id":73,"slug":28,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":28,"enrollmentInfo":82,"targetDuration":28,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":28,"overallStatus":92,"whyStopped":28,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"GCS Ramsay Santé pour l'Enseignement et la Recherche","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"LIDOCAINE Intravenous electric syringe","EXPERIMENTAL","Induction bolus 1.5 mg\u002Fkg (adjusted weight) intraoperatively, at the time of anesthetic induction, 15 to 30 min before incision.\n\nMaintenance 1.5 mg\u002Fkg\u002Fh until end of care \u002F discharge from the intensive care unit (reduced to 1 mg\u002Fkg\u002Fh in the post-interventional monitoring room), i.e. between 1 and 2 hours after the end of surgery.",[13,14,15,16],"Procedure: rachi morphine anesthesia","Procedure: laparotomy","Drug: Lidocaine IV","Drug: MORPHINE",{"label":18,"type":19,"description":11,"interventionNames":20},"PLACEBO Intravenous electric syringe","PLACEBO_COMPARATOR",[13,14,21,16],"Drug: Placebo",[23,29,33,38,42],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"PROCEDURE","rachi morphine anesthesia","Morphine spinal anesthesia is administered before general anesthesia, just after the patient has been admitted to the operating room.",[9,18],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"laparotomy","major digestive or abdominal surgery by laparotomy",[9,18],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":28},"DRUG","Lidocaine IV","KABI 20 mg\u002FmL solution for injection (ready-to-use ampoule, no dilution). Each ml of solution contains 20 mg lidocaine hydrochloride (monohydrate form), corresponding to 16.22 mg lidocaine.",[9],{"type":34,"name":39,"description":40,"armGroupLabels":41,"otherNames":28},"Placebo","Sodium chloride (NaCl) FRESENIUS 0.9% solution for infusion. Each ml contains 9 mg sodium chloride.",[18],{"type":34,"name":43,"description":44,"armGroupLabels":45,"otherNames":28},"MORPHINE","The auxiliary drug on which both experimental strategies are based is MORPHINE: Morphine hydrochloride AGUETTANT 0.1 mg\u002FmL Solution for injection (ready-to-use ampoule) for rachi anesthesia.",[9,18],[47],{"name":48,"role":49,"phone":50,"phoneExt":51,"email":52},"Florent SIGWALT, MD","CONTACT","688620169","+33","florent.sigwalt@gmail.com",[54],{"facility":55,"status":28,"city":56,"state":28,"zip":57,"country":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Hôpital Privé Jean Mermoz","Lyon","69008","France",{"type":60,"coordinates":61},"Point",[62,63],4.84789,45.74906,{"lat":63,"lon":62},[66],{"name":48,"role":49,"phone":28,"phoneExt":28,"email":52},{"type":68,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[70],{"name":71,"class":72},"Euraxi Pharma","INDUSTRY","100598834",false,"NCT07076641","Efficacy and Safety of Intravenous Lidocaine Versus Placebo in Patients Receiving Morphine-rachi Analgesia","Phase III, Randomized, Double-blind Study to Assess the Efficacy and Safety of Intravenous Lidocaine Versus Placebo in Patients Receiving Analgesic Morphine Rachi Anesthesia for Major Digestive or Abdominal Surgery by Laparotomy.","LIDORACHI","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Major digestive or abdominal surgery (pancreatic, hepatic, colorectal, gynecological, esophageal, gastric, duodenal, small intestine...);\n* Scheduled surgery;\n* Laparotomy;\n* Patient in agreement with morphine rachi anesthesia;\n* Social security affiliation;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Emergency surgery;\n* Contraindication to non-steroidal anti-inflammatory drugs: history of gastro duodenal ulcer, renal failure from stage 3 A or higher;\n* History of bradycardia and\u002For known conduction disorder (atrioventricular block) \u002F Pacemaker ;\n* Unstable coronary ;\n* Myocardial infarction \\\u003C6 months;\n* Severe cardiocirculatory insufficiency;\n* Severe hepatic insufficiency;\n* Allergy to morphine ;\n* Allergy to lidocaine;\n* Rhythm disorders at risk of sudden death (e.g. Brugada syndrome);\n* Flecaine as usual treatment;\n* Chronic pain with level II or III analgesics;\n* Gabapentinoids: pregabalin (Lyrica), gabapentin;\n* Drug addiction and substitute drugs;\n* Epileptic disorders ;\n* Myasthenia gravis;\n* Creatinine clearance below 10 mL\u002Fmin;\n* Hypokalemia, hypoxia or acid-base disorders;\n* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;\n* Inability to understand study information (due to linguistic, psychological, cognitive or literacy problems);\n* Women who are or may become pregnant\\* (of childbearing age, without effective contraception) or who are breast-feeding;\n* Patient deprived of liberty, under guardianship or unable to give consent.","ALL","18 Years",{"count":83,"type":84},76,"ESTIMATED","INTERVENTIONAL",[87],"PHASE3","The purpose of this study is to evaluate the superiority of IV lidocaine combined with morphine spinal anesthesia versus placebo combined with morphine spinal anesthesia, in reducing postoperative morphine consumption at 48 hours, in patients undergoing major digestive or abdominal surgery by laparotomy.",[90,91],"Digestive System Disease","Surgery","NOT_YET_RECRUITING","2026-06-30",{"date":95,"type":96},"2026-07-01","ACTUAL",{"date":98,"type":84},"2026-07",{"date":100,"type":84},"2027-07-30",{"name":5,"class":6},1]