[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561835":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":60,"collaborators":24,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":24,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":24,"enrollmentInfo":72,"targetDuration":24,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":47,"whyStopped":24,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University Hospital of Split","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Epidural analgesia","ACTIVE_COMPARATOR","An epidural catheter will be placed before induction to the anesthesia. A local anesthetic Levobupivacaine 0.25% (Levobupivakain Kabi ®, Fresenius Kabi Norge AS, Svinesundsveien, Norway, 5 mg\u002Fml) will be administered as a bolus dose during the surgery and continuously (0.125% levobupivacaine) during the first 24 hours postoperatively. After the intervention, patients will undergo general anesthesia.",[13],"Procedure: Epidural analgesia",{"label":15,"type":6,"description":16,"interventionNames":17},"Intrathecal opioid analgesia","Patients in the Intervention group will receive a single dose of 300 mcg of morphine (Morphine Kalceks ®, Kalceks, AS, Riga, Latvija, 10mg\u002Fml) intrathecally before induction to general anesthesia.",[18],"Procedure: Intrathecal opioid analgesia",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","After establishing standard non-invasive monitoring of vital functions (electrocardiogram, blood pressure, peripheral oxygen saturation) and securing intravenous access, the patient will be seated. After sterile field preparation, a local anesthetic (2% lidocaine) will be administered at the site of the planned puncture. The epidural space will be identified at the level of the tenth thoracic intervertebral space using the loss of resistance technique and an 18G Tuohy epidural needle. After placing the epidural catheter, 4 ml of local anesthetic Levobupivacaine 0.25% will be administered into the epidural space. After inducing general anesthesia, an additional 4 ml of Levobupivacaine 0.25% will be administered before the surgical incision. Subjects in the control group will receive an infusion of 0.125% Levobupivacaine for 24 hours after the procedure.",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":28},"After establishing standard non-invasive monitoring of vital functions (electrocardiogram, blood pressure, peripheral oxygen saturation) and securing intravenous access, the patient will be seated. After sterile field preparation, a local anesthetic (2% lidocaine) will be administered at the site of the planned intrathecal puncture. Subsequently, at the selected site, the dura will be punctured using a spinal needle (25G Quincke spinal needle), and 0.3 mg of morphine will be administered to the patient. Following the intervention, the patient will be induced into general anesthesia.",[15],[29],"Intrathecal morphine analgesia",[31],{"name":32,"affiliation":33,"role":34},"Svjetlana Došenović, MD Phd","UH Split","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":24,"email":40},"Petra Bajto, MD","CONTACT","+385955234851","p.bajto@gmail.com",{"name":42,"role":38,"phone":24,"phoneExt":24,"email":43},"Lenko Šarić, Asst. Prof.","lenko.saric@gmail.com",[45],{"facility":46,"status":47,"city":48,"state":24,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Univeristy Hospital of Split","RECRUITING","Split","21000","Croatia","HR",{"type":53,"coordinates":54},"Point",[55,56],16.43915,43.50891,{"lat":56,"lon":55},[59],{"name":37,"role":38,"phone":39,"phoneExt":24,"email":24},{"type":34,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Lenko Saric","Assistant professor","100561835","phase-1-comparison-between-epidural-analgesia-and-intrathecal-opioid-analgesia-for-pain-management-in-open-nephrectomy-100561835",false,"NCT06595329","Comparison Between Epidural Analgesia and Intrathecal Opioid Analgesia for Pain Management in Open Nephrectomy","Comparison Between Epidural Analgesia and Intrathecal Opioid Analgesia for Pain Management in Open Nephrectomy: Prospective Randomized Controlled Trial","Inclusion Criteria:\n\n* Adult patients over the age of 18, scheduled for an open radical or partial nephrectomy due to RCC.\n* American Society of Anesthesiologists (ASA) physical status classification I-III.\n\nExclusion Criteria:\n\n* Patients who refuse to participate in this study.\n* Patients with BMI \\> 35 kg\u002Fm2 or \\\u003C 15 kg\u002Fm2.\n* Patients with renal dysfunction (eGFR \\\u003C15 or requirement of renal replacement therapy), liver dysfunction (Child-Pugh class C), and heart failure (NYHA IV).\n* Patients with ASA physical status classification ≥ IV.\n* Patients with contraindication for the interventions planned for in this study (allergies to anesthetic drugs used in this study, coagulation disorders, and infection at the injection site).\n* Patients with chronic opioid dependence.\n* Patients unable to communicate preoperatively due to severe dementia, language barrier, or neuropsychiatric disorder.\n* Patients for whom it is impossible to carry out the aforementioned interventions for technical reasons.","ALL","18 Years",{"count":73,"type":74},40,"ESTIMATED","INTERVENTIONAL",[77],"PHASE1","Nephrectomy is a surgical procedure of choice for patients suffering from renal cell carcinoma (RCC). Even though the laparoscopic approach is considered to cause fewer complications and reduce hospital stay, open surgery is still often performed. Open nephrectomy causes significant acute postoperative pain, and it can also lead to the development of chronic postoperative pain. Pain management is important for the overall recovery of patients undergoing major surgery such as open nephrectomy and it is a part of the enhanced recovery after surgery (ERAS) program.\n\nIn this prospective randomized clinical study, we plan to compare two different approaches to pain management regarding the level of acute pain (first 72 hours), side effects, systemic analgesics consumption, and hospital stay.\n\nOur hypothesis are that intrathecal opioid administration significantly reduces acute postoperative pain compared to epidural analgesia in patients undergoing open radical or partial nephrectomy. We also hypothesize that the intrathecal opioid administration is associated with a lower incidence of adverse effects compared to epidural analgesia and shorter ICU length of stay.",[80,81,82],"Pain","Renal Cancer","Surgical Procedure, Unspecified",[84,85,86],"Pain management","open nephrectomy","renal cell carcinoma","2025-03-05",{"date":89,"type":90},"2025-03-10","ACTUAL",{"date":92,"type":90},"2025-01-15",{"date":94,"type":74},"2025-12-31",{"name":5,"class":6},1]