[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501079":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":59,"collaborators":26,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":26,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":26,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Medical University of Warsaw","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Multimodal analgesia group","PLACEBO_COMPARATOR","Patients receiving placebo per os 1 hour preoperatively and anesthesia with standard, multimodal analgesia afterwards.",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Multimodal analgesia with preemptive pregabalin group","EXPERIMENTAL","Patients receiving pregabalin 150mg per os 1 hour preoperatively and anesthesia with standard, multimodal analgesia afterwards.",[19],"Drug: Pregabalin 150mg",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Pregabalin 150mg","Single dose of pregabalin 150mg in a capsule per os 1 hour before start of the operation.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","1 capsule containing placebo per os 1 hour before start of the operation.",[9],[32],{"name":33,"affiliation":5,"role":34},"Piotr Mieszczański, MD","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","669643205","+48","piotr.mieszczanski@gmail.com",[42],{"facility":43,"status":44,"city":45,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Szpital Kliniczny Dzieciatka Jezus","RECRUITING","Warsaw","02-005","Poland","PL",{"type":50,"coordinates":51},"Point",[52,53],21.01178,52.22977,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":58,"phoneExt":26,"email":40},"Piotr Mieszczanski","+48669643205",{"type":60,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100501079","phase-4-pregabalin-in-the-obese-patients-undergoing-laparoscopic-sleeve-gastrectomy-lsg-100501079",false,"NCT05804591","Pregabalin in the Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy (LSG).","The Effect of Preemptive Oral Pregabalin As an Element of Multimodal Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy. a Randomized, Prospective, Double Blind Study.","Inclusion Criteria:\n\n* Sleeve gastrectomy in patients with BMI \\> 40 or \\>35 with comorbidities\n* Written informed consent\n\nExclusion Criteria:\n\n* Patient's refusal\n* Known allergies to study medication\n* Inability to comprehend or participate In pain scoring scale\n* Inability to use intravenous patient controlled analgesia\n* Changes of operation extent during procedure\n* Revisional operations\n* End stage organ failure","ALL","18 Years",{"count":71,"type":72},90,"ESTIMATED","INTERVENTIONAL",[75],"PHASE4","The aim of this clinical trial is to assess preemptive oral pregabalin administration in the obese patients undergoing laparoscopic sleeve gastrectomy. The main aims of the study are to evaluate postoperative pain treatment and effect on the intraoperative hemodynamical stability.\n\nThe participants will be divided into 2 groups: with or without preemptive pregabalin administration.",[78,79,80,81],"Obesity","Postoperative Pain","Postoperative Nausea and Vomiting","Opioid Use",[83,78,84,85],"Laparoscopic sleeve gastrectomy","Pregabalin","Multimodal analgesia","2024-09-12",{"date":88,"type":89},"2024-09-19","ACTUAL",{"date":91,"type":89},"2023-04-24",{"date":93,"type":72},"2025-08-01",{"name":5,"class":6},1]