[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638283":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":45,"responsibleParty":182,"collaborators":34,"id":184,"slug":185,"hasResults":186,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":186,"sex":192,"minAge":193,"maxAge":34,"enrollmentInfo":194,"targetDuration":34,"studyType":197,"phases":198,"briefSummary":200,"conditions":201,"keywords":203,"overallStatus":209,"whyStopped":34,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":219},{"fullName":5,"class":6},"Rennes University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lidocaine Group","EXPERIMENTAL","Standard anaesthesia protocol with lidocaine",[13],"Drug: Standardized General Anesthesia Induction and Maintenance Protocol incorporating Intravenous Lidocaine",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","PLACEBO_COMPARATOR","Standard anaesthesia protocol with placebo (NaCl)",[19],"Drug: Standardized General Anesthesia Induction and Maintenance Protocol incorporating Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Standardized General Anesthesia Induction and Maintenance Protocol incorporating Intravenous Lidocaine","Standard general anaesthesia induction protocol with pre-defined bolus of lidocaine and standard general anaesthesia maintenance protocol with pre-defined continuous intravenous infusion of lidocaine",[9],[27],"Lidocaine",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Standardized General Anesthesia Induction and Maintenance Protocol incorporating Placebo","Standard general anaesthesia induction protocol with pre-defined bolus of placebo and standard general anaesthesia maintenance protocol with pre-defined continuous intravenous infusion of placebo",[15],[33],"Placebo",null,[36,41],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Pr Hélène BELOEIL, MD","CONTACT","+33299282422","helene.beloeil@chu-rennes.fr",{"name":42,"role":38,"phone":43,"phoneExt":34,"email":44},"Alain CARO","+33299289496","alain.caro@chu-rennes.fr",[46,65,80,95,110,125,140,155,167],{"facility":47,"status":34,"city":48,"state":34,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Centre 03 - CHU de Clermont-Ferrand, Hôpital Estaing","Clermont-Ferrand","63100","France","FR",{"type":53,"coordinates":54},"Point",[55,56],3.08682,45.77969,{"lat":56,"lon":55},[59,63],{"name":60,"role":38,"phone":61,"phoneExt":34,"email":62},"Ugo SCHIFF, MD","+33473755168","uschiff@chu-clermontferrand.fr",{"name":60,"role":64,"phone":34,"phoneExt":34,"email":34},"PRINCIPAL_INVESTIGATOR",{"facility":66,"status":34,"city":67,"state":34,"zip":68,"country":50,"countryCode":51,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Centre 04 - Centre Hospitalier Départemental de la Vendée","La Roche-sur-Yon","85000",{"type":53,"coordinates":70},[71,72],-1.42757,46.66974,{"lat":72,"lon":71},[75,79],{"name":76,"role":38,"phone":77,"phoneExt":34,"email":78},"Alexis DUCHALAIS, MD","+33251446237","alexis.duchalais@ght85.fr",{"name":76,"role":64,"phone":34,"phoneExt":34,"email":34},{"facility":81,"status":34,"city":82,"state":34,"zip":83,"country":50,"countryCode":51,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Centre 02 - CH Louis Pasteur, Les Hôpitaux de Chartres","Le Coudray","28630",{"type":53,"coordinates":85},[86,87],1.50057,48.42115,{"lat":87,"lon":86},[90,94],{"name":91,"role":38,"phone":92,"phoneExt":34,"email":93},"Nidhal CHEBBI, MD","+33237303030","nchebbi@ch-chartres.fr",{"name":91,"role":64,"phone":34,"phoneExt":34,"email":34},{"facility":96,"status":34,"city":97,"state":34,"zip":98,"country":50,"countryCode":51,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Centre 05 - CHU de Lille","Lille","59000",{"type":53,"coordinates":100},[101,102],3.05512,50.63391,{"lat":102,"lon":101},[105,109],{"name":106,"role":38,"phone":107,"phoneExt":34,"email":108},"Gilles LEBUFFE, MD","+330320444508","gilles.lebuffe@chru-lille.fr",{"name":106,"role":64,"phone":34,"phoneExt":34,"email":34},{"facility":111,"status":34,"city":112,"state":34,"zip":113,"country":50,"countryCode":51,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Centre 06 - Centre Léon Bérard","Lyon","69008",{"type":53,"coordinates":115},[116,117],4.84789,45.74906,{"lat":117,"lon":116},[120,124],{"name":121,"role":38,"phone":122,"phoneExt":34,"email":123},"Grégoire WALLON, MD","+33478782971","gregoire.wallon@lyon.unicancer.fr",{"name":121,"role":64,"phone":34,"phoneExt":34,"email":34},{"facility":126,"status":34,"city":127,"state":34,"zip":128,"country":50,"countryCode":51,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Centre 07 - CHU Nice, Hôpital Archet 2","Nice","06200",{"type":53,"coordinates":130},[131,132],7.26608,43.70313,{"lat":132,"lon":131},[135,139],{"name":136,"role":38,"phone":137,"phoneExt":34,"email":138},"Romain ROZIER, MD","+33492036647","rozier.r@chu-nice.fr",{"name":136,"role":64,"phone":34,"phoneExt":34,"email":34},{"facility":141,"status":34,"city":142,"state":34,"zip":143,"country":50,"countryCode":51,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Centre 08 - AP-HP - Sorbonne Université, Hôpital de la Pitié-Salpêtrière","Paris","75013",{"type":53,"coordinates":145},[146,147],2.3488,48.85341,{"lat":147,"lon":146},[150,154],{"name":151,"role":38,"phone":152,"phoneExt":34,"email":153},"Alexandre SITBON, MD","+33184827379","alexandre.sitbon@aphp.fr",{"name":151,"role":64,"phone":34,"phoneExt":34,"email":34},{"facility":156,"status":34,"city":157,"state":34,"zip":158,"country":50,"countryCode":51,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Centre 01 - CHU de RENNES, Hôpital Pontchaillou","Rennes","35000",{"type":53,"coordinates":160},[161,162],-1.67431,48.11109,{"lat":162,"lon":161},[165,166],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},{"name":37,"role":64,"phone":34,"phoneExt":34,"email":34},{"facility":168,"status":34,"city":169,"state":34,"zip":170,"country":50,"countryCode":51,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Centre 09 - CHU Toulouse, Hôpital Rangueil","Toulouse","31400",{"type":53,"coordinates":172},[173,174],1.44367,43.60426,{"lat":174,"lon":173},[177,181],{"name":178,"role":38,"phone":179,"phoneExt":34,"email":180},"Guillaume PORTA BONETE, MD","+33561323565","porta-bonete.g@chu-toulouse.fr",{"name":178,"role":64,"phone":34,"phoneExt":34,"email":34},{"type":183,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100638283","phase-4-intravenous-lidocaine-for-hepatectomy-100638283",false,"NCT07590830","Intravenous Lidocaine for Hepatectomy","Effect of Perioperative Intravenous Lidocaine on Postoperative Opioid Related-side Effects After Open HEPatectomy: a Multicentre Prospective Randomized Controlled Study","ILHEP","Inclusion Criteria:\n\n* Inclusion criterion 1 : Age ≥ 18 years\n* Inclusion criterion 2 : Undergoing a scheduled surgery for open hepatectomy\n* Inclusion criterion 3 : Effective contraception in accordance with CFTG recommendations\n* Inclusion criterion 4 : Having received oral and written information about the protocol and having signed a consent form to take part in this research\n* Inclusion criterion 5 : Affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Exclusion criterion 1 : Weight \\> 100 kg\n* Exclusion criterion 2 : Allergy or contraindication to lidocaine or one of its excipients and, in particular:\n\n  * Known hypersensitivity to lidocaine hydrochloride, to amide-type local anesthetics, or to any of the excipients (sodium chloride, sodium hydroxide solution or concentrated hydrochloric acid solution, water for injection)\n  * Treatment with following antiarythmic medication : class I, class III or Sotalol\n  * Heart failure NYHA grade 3-4, AV-block \\>1, without pacemaker\n  * Acute porphyria\n  * Recurrent porphyrias\n  * Uncontrolled epilepsy \u002F Seizure at enrollment\n* Exclusion criterion 3 : Allergy to one of the drugs used for anaesthesia or one of their excipients\n* Exclusion criterion 4 : Nefopam contraindication and, in particular:\n\n  * Renal insufficiency (Creatinine clearance \\\u003C 15 mL\u002Fmin)\n  * Untreated glaucoma\n  * Uncontrolled epilepsy\n  * Allergy\n* Exclusion criterion 5 : Ketoprofen contraindication and, in particular:\n\n  * Renal insufficiency (Creatinine clearance \\\u003C 50 mL\u002Fmin)\n  * Inflammatory bowel disease\n  * Allergy\n* Exclusion criterion 6 : Urgent surgery\n* Exclusion criterion 7 : Transplant surgery or transplanted patients\n* Exclusion criterion 8 : Surgery with planned regional anaesthesia\n* Exclusion criterion 9 : Patient with a preoperative Sp02 \\\u003C 95%\n* Exclusion criterion 10 : Obstructive sleep apnea syndrome\n* Exclusion criterion 11 : Severe hepatic insufficiency (Prothrombin Ratio \\\u003C 15%)\n* Exclusion criterion 12 : Patient with an ongoing opioid medication that will blur the results\n* Exclusion criterion 13 : Adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty, pregnant or breast-feeding women, minors, persons unable to express their consent, persons hospitalized for a different reason\n* Exclusion criterion 14 : Known participation in other interventional research (RIPH1 or RIPH2)","ALL","18 Years",{"count":195,"type":196},312,"ESTIMATED","INTERVENTIONAL",[199],"PHASE4","Liver resection is increasingly performed for hepatic tumors, mainly primary liver cancers and resectable metastases, but also for some benign lesions. Postoperative pain is often significant, regardless of the surgical technique, making effective pain control essential to promote early mobilization and reduce complications.\n\nCurrent standard care relies on multimodal analgesia, combining several drugs administered during surgery, with morphine administered as rescue therapy when required. Morphine is associated with side effects such as nausea, vomiting, ileus, hypoxemia, opioid-induced hyperalgesia, and transient cognitive impairment. Therefore, there is a need to optimize pain management while reducing opioid consumption and related adverse effects.\n\nIntravenous (IV) lidocaine has well-documented anti-inflammatory effects and is effective against neuropathic pain. Several studies have shown that intravenous lidocaine may be associated with improved analgesia, reduced opioid consumption, shorter hospital stay, and decreased postoperative ileus, nausea, and vomiting-particularly in abdominal and genitourinary surgeries. Therefore, Intravenous (IV) lidocaine may be a valuable alternative for postoperative pain management after liver surgery.\n\nNational guidelines now recommend perioperative Intravenous (IV) lidocaine for abdominal surgeries but its efficacy in liver surgery has not yet been established due to a lack of specific evidence (more specific data are needed). Findings from other types of abdominal surgery suggest a potential benefit, which should be confirmed by dedicated clinical trials and robust multicenter evaluation such as the ILHEP protocol.\n\nThe goal of this clinical trial is to assess the effect of intravenous perioperative lidocaine on postoperative opioid related-side effects and to formally confirm the safety of lidocaine during hepatic surgical procedures. The hypothesis is that Intravenous (IV) lidocaine compared with placebo (a look-alike substance that contains no drug e.g. a saline solution) would improve postoperative outcome by reducing opioid related side-effects in patients undergoing liver surgery and benefitting of the same baseline analgesia.\n\nIn the context of this trial, patients will receive either intravenous lidocaine or placebo according to their assigned randomization group during standardized general anesthesia, and will then be followed throughout their hospital stay until discharge or up to a maximum of 28 days.\n\nAn ancillary study will be conducted in patients enrolled at the coordinating center in Rennes to assess exposure to lidocaine during intravenous administration and to evaluate the relationship between blood concentrations and adverse events.",[202],"Hepatectomy",[27,204,205,206,207,202,208],"Pain management","Analgesics","Postoperative opioid related-side effects","Double-Blind Method","Anesthesia","NOT_YET_RECRUITING","2026-05-12",{"date":212,"type":213},"2026-05-15","ACTUAL",{"date":215,"type":196},"2026-08-01",{"date":217,"type":196},"2028-09-01",{"name":5,"class":6},9]