[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100271933":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":25,"locations":34,"responsibleParty":55,"collaborators":25,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":80,"whyStopped":81,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Centre Hospitalier Universitaire, Amiens","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ropivacaine","ACTIVE_COMPARATOR","Ropivacaine 7.5 mg\u002FmL administration",[13],"Drug: Ropivacaine administration",{"label":15,"type":16,"description":17,"interventionNames":18},"Sodium chloride","PLACEBO_COMPARATOR","NaCl 0.9% administration",[19],"Drug: Sodium chloride administration",[21,26],{"type":22,"name":23,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Sodium chloride administration",[15],null,{"type":22,"name":27,"description":27,"armGroupLabels":28,"otherNames":25},"Ropivacaine administration",[9],[30],{"name":31,"affiliation":32,"role":33},"Jean-Marc REGIMBEAU, MD, PhD","CHU Amiens","PRINCIPAL_INVESTIGATOR",[35,46],{"facility":32,"status":25,"city":36,"state":25,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":25},"Amiens","80054","France","FR",{"type":41,"coordinates":42},"Point",[43,44],2.3,49.9,{"lat":44,"lon":43},{"facility":47,"status":25,"city":48,"state":25,"zip":49,"country":38,"countryCode":39,"cosmosGeoPoint":50,"geoPoint":54,"contacts":25},"CH Beauvais","Beauvais","60000",{"type":41,"coordinates":51},[52,53],2.08333,49.43333,{"lat":53,"lon":52},{"type":56,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100271933","phase-3-evaluation-of-the-interest-of-the-instillation-of-saline-intraperitoneally-insi--versus-instillation-of-naropin-the-surgical-site-versus-lung-recruitment-maneuvers--pvm--in-the-management-of-pain-after-laparoscopic-cholecystectomy-in-ambulatory-care-100271933",false,"NCT02819544","Evaluation of the Interest of the Instillation of Saline Intraperitoneally (INSI ) Versus Instillation of Naropin the Surgical Site Versus Lung Recruitment Maneuvers ( PVM ) in the Management of Pain After Laparoscopic Cholecystectomy in Ambulatory Care","Prospective, Two-center , Randomized, ITT , Parallel Group Evaluating the Interest of the Instillation of Saline Intraperitoneally (INSI ) Versus Instillation of Naropin the Surgical Site Versus Lung Recruitment Maneuvers ( PVM ) in the Management of Pain After Laparoscopic Cholecystectomy in Ambulatory Care","VSD","Inclusion Criteria:\n\n* Patient aged 18 to 80 years\n* Patients with biliary pathology requiring cholecystectomy\n* Patients with signed consent\n* Patient eligible to outpatient care\n* No allergy to Naropin\n* Support by laparoscopy\n* Patients affiliated to a social security s\n\nExclusion Criteria:\n\n* Contraindications for laparoscopy\n* Contraindications to outpatient surgery\n* Patients with an allergy to paracetamol or tramadol\n* Patient with an addiction to painkillers and \u002F or alcohol\n* Patient with a disease causing chronic pain\n* Patient using analgesics bearing 1 , 2 or 3 chronically\n* Pregnant or breastfeeding women , of reproductive age without effective contraception\n* Minor Patient,\n* Contraindication to surgery,\n* Physical or psychological state does not allow the patient's participation in the study ,","ALL","18 Years","80 Years",{"count":69,"type":70},0,"ACTUAL","INTERVENTIONAL",[73],"PHASE3","Known to reduce analgesics and length of hospitalization in conventional surgery, laparoscopy is characterized by frequent post-operative pain and can decrease the patient's quality of immediate postoperative life and sometimes the results of decision ambulatory care.\n\nIn order to reduce these postoperative pain, various methods have been evaluated in numerous studies to determine their analgesic role.\n\nAs part of abdominal surgery, local anesthetics (Naropin (Ropivacaine)) are generally administered in the end of surgery to reduce postoperative pain and promote recovery of the patient. In addition, it is also possible to instill the anesthetic directly into the abdominal cavity reducing pain transmitted by nociceptor viscera.\n\nIn recent years, new methods have been proposed such as lung recruitment maneuvers and the instillation of saline solution to reduce postoperative pain.\n\nHowever, no recommendation is on the use of intraperitoneal saline under the management of postoperative pain after laparoscopic cholecystectomy in ambulatory care.",[76,77],"Surgery","Pain",[79],"Digestive System","WITHDRAWN","investigator choice","2020-07-15",{"date":84,"type":70},"2020-07-17",{"date":86,"type":70},"2016-09",{"date":88,"type":70},"2017-05-10",{"name":5,"class":6},2]