[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622020":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":37,"studyPopulation":26,"armGroups":38,"interventions":51,"overallOfficials":26,"centralContacts":59,"locations":66,"responsibleParty":85,"collaborators":26,"id":89,"slug":26,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":26,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":111,"whyStopped":26,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Jagiellonian University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Opioid consumption","measurement of total oxycodone consumption in the postoperative period","up to 48 hours after surgery",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Pain assessment","Assessment of pain at 1, 2, 6, 12, 24, and 48 hours after surgery by NRS scale (0-10, 0 - no pain, 10 worst pain imaginable)","at 1, 2, 6, 12, 24, and 48 hours after surgery",{"measure":19,"description":20,"timeFrame":21},"PONV","assessment of the occurrence of postoperative nausea and vomiting (PONV)","up to 48 h after surgery",{"measure":23,"description":24,"timeFrame":25},"Quality Of Recovery","QOR-15 questionnaire to assess quality of life and PQA-10 questionnaire. The QOR-15 is a 15 items questionnaire which provides a valid and efficient evaluation of the postoperative quality of recovery.\n\nThe QoR 15 score is a score of 15 items, each scored from 0 to 10. These items assess 5 dimensions of post-operative recovery: pain, physical comfort, functional autonomy, emotions and psychological support.\n\nThese 15 items represent the quality of post-operative rehabilitation in its physical and mental dimensions","on the 7th day after surgery",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":33},"TRIPLE",[34,35,36],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR","In our study, the investigators would like to compare the measurement of total oxycodone consumption in the postoperative period in both groups and whether the use of opioid-free anesthesia would reduce opioid consumption by 30%. The secondary objective will be to assess pain in both groups during the first 48 postoperative hours in patients undergoing pancreatic surgery. Patients would be randomly assigned to anesthesia with and without opioids at 1, 2, 6, 12, 24, and 48 hours after surgery. Other secondary objectives include assessing the incidence of postoperative nausea and vomiting (PONV), adverse drug reactions, particularly cardiac arrhythmias, and the impact on persistent postoperative pain. On day 7 after surgery, each patient will receive the QOR-15 questionnaire to assess quality of life and the PQA-10 questionnaire.",[39,45],{"label":40,"type":41,"description":42,"interventionNames":43},"Balanced anesthesia with opioids","ACTIVE_COMPARATOR","Patients who will have pancreatic operation under balanced anesthesia including opioids",[44],"Drug: Balanced anesthesia with opioids",{"label":46,"type":47,"description":48,"interventionNames":49},"Opioid Free Anesthesia (OFA)","EXPERIMENTAL","Patients who willl have pancreatic operation under Opioid Free anesthesia",[50],"Other: Opioid Free Anesthesia (OFA)",[52,55],{"type":6,"name":46,"description":53,"armGroupLabels":54,"otherNames":26},"Patients who will have pancreatic operation under Opioid Free anesthesia",[46],{"type":56,"name":40,"description":57,"armGroupLabels":58,"otherNames":26},"DRUG","Patients who will hav pancreatic operation under balanced anesthesia including opioids",[40],[60],{"name":61,"role":62,"phone":63,"phoneExt":64,"email":65},"Michal Cicio, MD","CONTACT","124001800","+48","michal.cicio@uj.edu.pl",[67],{"facility":68,"status":26,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Department of Intensive Interdisciplinary Care, Collegium Medicum, Jagiellonian University","Krakow","Lesser Poland Voivodeship","30-688","Poland","PL",{"type":75,"coordinates":76},"Point",[77,78],19.93658,50.06143,{"lat":78,"lon":77},[81],{"name":82,"role":62,"phone":83,"phoneExt":26,"email":84},"Tomasz Skladzien, phd md","+48 12 400 1800","tomasz.skladzien@uj.edu.pl",{"type":86,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Tomasz Skladzien","older asistent","100622020",false,"NCT07378189","Opioid-free Anesthesia as an Alternative to General Anesthesia in Patients Undergoing Laparoscopic Peripheral Pancreatic Resection","OFAPP","Inclusion Criteria:\n\n* Patient consent to participate in the study\n* Qualified for laparoscopic peripheral pancreatic resection\n* Age 18-80 years\n* ASA II and III\n\nExclusion Criteria:\n\n* Patient refusal to participate in the study\n* Inability to operate a PCA pump\n* Lack of understanding of the NRS scale\n* Hypersensitivity to anesthetics\n* First- or second-degree heart block.","ALL","18 Years","80 Years",{"count":99,"type":100},200,"ESTIMATED","INTERVENTIONAL",[103],"NA","Opioid-free anesthesia is not associated with greater pain than opioid anesthesia and is associated with reduced postoperative pain.",[106],"Pain Management",[108,109,110],"Pain","OFA","Opioid Free Anesthesia","NOT_YET_RECRUITING","2026-01-28",{"date":114,"type":115},"2026-01-30","ACTUAL",{"date":117,"type":100},"2026-02-01",{"date":119,"type":100},"2027-12-31",{"name":5,"class":6},1]