[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648465":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":37,"centralContacts":38,"locations":44,"responsibleParty":67,"collaborators":37,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":37,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":37,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":47,"whyStopped":37,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Hitit University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Nephrostomy Tract Bupivacaine Infiltration","EXPERIMENTAL","Participants in this arm will receive standard postoperative systemic analgesia. In addition, at the end of percutaneous nephrolithotomy, 20 mL of 0.25% bupivacaine will be infiltrated along the nephrostomy tract, including the skin, subcutaneous tissue, muscular layers, and tissues surrounding the nephrostomy tract.",[13,14],"Drug: Bupivacaine","Drug: Intravenous Tramadol and Paracetamol",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard Systemic Analgesia","ACTIVE_COMPARATOR","Participants in this arm will receive the standard postoperative systemic analgesia protocol, including intravenous tramadol and intravenous paracetamol. Rescue opioid analgesia will be administered when clinically required. No local or regional analgesic intervention will be performed.",[14],[21,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Bupivacaine","A total of 20 mL of 0.25% bupivacaine will be administered by local infiltration along the nephrostomy tract at the end of surgery. The infiltration will include the skin, subcutaneous tissue, muscular layers, and tissues surrounding the nephrostomy tract.",[9],[27,28,29],"Bupivacaine hydrochloride","Nephrostomy tract local anesthetic infiltration","Peritubal bupivacaine infiltration",{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Intravenous Tramadol and Paracetamol","Standard postoperative systemic analgesia consisting of intravenous tramadol and intravenous paracetamol will be administered according to the institutional analgesia protocol. Rescue opioid analgesia will be provided when clinically required.",[9,16],[35,36],"Standard postoperative analgesia","Intravenous tramadol and acetaminophen",null,[39],{"name":40,"role":41,"phone":42,"phoneExt":37,"email":43},"MUSTAFA SERDAR ÇAĞLAYAN","CONTACT","+905074311951","serdar.09.09@hotmail.com",[45],{"facility":46,"status":47,"city":48,"state":48,"zip":49,"country":50,"countryCode":37,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye","RECRUITING","Çorum","19040","Turkey (Türkiye)",{"type":52,"coordinates":53},"Point",[54,55],34.95333,40.54889,{"lat":55,"lon":54},[58,62,65],{"name":59,"role":41,"phone":60,"phoneExt":37,"email":61},"MUSA EKİCİ","+90 505 751 6341","musaekici@hitit.edu.tr",{"name":63,"role":64,"phone":37,"phoneExt":37,"email":37},"AHMET TAŞCI","SUB_INVESTIGATOR",{"name":66,"role":64,"phone":37,"phoneExt":37,"email":37},"METİN KIZGIN",{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"PRINCIPAL_INVESTIGATOR","Mustafa Serdar CAGLAYAN","Assistant Professor, MD","100648465","nephrostomy-tract-infiltration-for-pain-control-after-pcnl-100648465",false,"NCT07721571","Nephrostomy Tract Infiltration for Pain Control After PCNL","Efficacy of Nephrostomy Tract Local Anesthetic Infiltration for Postoperative Pain Control Following Prone Percutaneous Nephrolithotomy: A Prospective Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults aged 18 to 75 years\n* Scheduled to undergo elective percutaneous nephrolithotomy in the prone position\n* Classified as American Society of Anesthesiologists physical status I-III\n* Able to understand and complete postoperative pain assessments using the Visual Analog Scale\n* Willing to participate in the study\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to bupivacaine or other local anesthetic agents Coagulopathy or clinically significant bleeding disorder Chronic opioid use History of a neurological disorder that may affect pain perception or assessment Neurological or psychiatric condition preventing reliable postoperative pain assessment Active urinary tract infection or sepsis American Society of Anesthesiologists physical status IV or higher Requirement for multiple percutaneous access tracts Bilateral percutaneous nephrolithotomy Requirement for postoperative intensive care Refusal or inability to provide written informed consent","ALL","18 Years","75 Years",{"count":82,"type":83},60,"ESTIMATED","INTERVENTIONAL",[86],"NA","This prospective, randomized, controlled clinical trial aims to evaluate the effectiveness of nephrostomy tract local anesthetic infiltration for postoperative pain control in patients undergoing prone percutaneous nephrolithotomy. Eligible patients will be randomly assigned to either a control group receiving standard systemic postoperative analgesia or an intervention group receiving standard analgesia plus infiltration of 20 mL of 0.25% bupivacaine along the nephrostomy tract at the end of surgery. Postoperative pain will be assessed using the Visual Analog Scale at 1, 6, 12, and 24 hours. Secondary outcomes will include time to first analgesic requirement, total opioid consumption during the first 24 hours, need for rescue analgesia, time to mobilization, length of hospital stay, and treatment-related complications. The study is designed to determine whether nephrostomy tract infiltration provides a simple, safe, and effective adjunct for reducing pain and analgesic consumption after percutaneous nephrolithotomy.",[89,90],"Postoperative Pain","Kidney Calculi",[92,93,94,95],"local anesthetic infiltration","Percutaneous nephrolithotomy","peritubal infiltration","postoperative pain","2026-07-18",{"date":98,"type":99},"2026-07-23","ACTUAL",{"date":101,"type":99},"2026-07-17",{"date":103,"type":83},"2027-06-11",{"name":5,"class":6},1]