[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587084":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":76,"collaborators":26,"id":78,"slug":26,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":26,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":26,"overallStatus":67,"whyStopped":26,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Institute of Oncology Ljubljana","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lidokaine arm","ACTIVE_COMPARATOR","Patients who will receive intravenous lidocaine.",[13],"Drug: Lidocaine",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo arm","PLACEBO_COMPARATOR","Patients who will receive placebo.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Lidocaine","intravenous infusion of lidocaine",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","saline solution intravenous infusion",[15],[32],{"name":33,"affiliation":5,"role":34},"Nikola Bešić, MD","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Eva Černe, MD","CONTACT","0038615879844","ecerne@onko-i.si",[42,66],{"facility":5,"status":43,"city":44,"state":26,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"NOT_YET_RECRUITING","Ljubljana","1000","Slovenia","SI",{"type":49,"coordinates":50},"Point",[51,52],14.50513,46.05108,{"lat":52,"lon":51},[55,57,58,60,62,64],{"name":37,"role":38,"phone":56,"phoneExt":26,"email":40},"+386158799844",{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"name":37,"role":59,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"name":61,"role":59,"phone":26,"phoneExt":26,"email":26},"Branka Stražišar, MD",{"name":63,"role":59,"phone":26,"phoneExt":26,"email":26},"Nina Kovačevič, MD",{"name":65,"role":59,"phone":26,"phoneExt":26,"email":26},"Alojz Ihan, MD",{"facility":5,"status":67,"city":44,"state":26,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":68,"geoPoint":70,"contacts":71},"RECRUITING",{"type":49,"coordinates":69},[51,52],{"lat":52,"lon":51},[72],{"name":73,"role":38,"phone":74,"phoneExt":26,"email":75},"Nikola Bešić, MD, PhD","00386015879935","nbesic@onko-i.si",{"type":77,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100587084",false,"NCT06923787","Effect of Perioperative Intravenous Infusion of Lidocaine on the Postoperative Course and the Immune Response in Patients Undergoing Surgery for Colon Cancer - the PILDI Study","PILDI","Inclusion Criteria:\n\n* colon cancer of any stage of the disease for which elective laparoscopic colon resection and colonic anastomosis will be performed,\n* age of patients between 18 and 80 years,\n* low to moderate risk of anesthesia (ASA up to and including 3),\n* ability to understand the study and to sign an informed consent to participate in the study\n\nExclusion Criteria:\n\n* patients receiving neoadjuvant chemotherapy,\n* pregnancy or breastfeeding,\n* known allergy to lidocaine\n* cardiac rhythm disturbances (bradycardia \\\u003C 45 beats\u002Fmin, complete heart block, use of group III antiarrhythmics),\n* status post cardiac arrest,\n* porphyria,\n* myasthenia gravis,\n* severe hepatic impairment (cirrhosis, ascites, bleeding disorders, jaundice, encephalopathy),\n* renal disease (hamodialysis, creatinine clearance \\\u003C30 mL\u002Fmin),\n* epilepsy,\n* active infection,\n* presence of viral or systemic fungal disease,\n* uncontrolled psychotic state,\n* ulcerative gastric or duodenal disease,\n* chronic corticosteroid therapy.","ALL","18 Years","80 Years",{"count":88,"type":89},100,"ESTIMATED","INTERVENTIONAL",[92],"PHASE2","There are very few data in the literature on changes in inflammatory markers when lidocaine is administered perioperatively in patients with colorectal cancer. In patients undergoing surgery for colon cancer, the aim is to conduct a double-blind placebo-controlled study to determine differences in levels of pro-inflammatory markers, postoperative pain and opioid analgesic consumption in the first two days after surgery, and the time to first postoperative bowel movement. Groups of patients receiving perioperative lidocaine infusion, high dose dexamethasone or placebo will be compared.",[95],"Colon Cancer","2026-02-03",{"date":98,"type":99},"2026-02-05","ACTUAL",{"date":96,"type":99},{"date":102,"type":89},"2028-07-01",{"name":5,"class":6},2]