[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588001":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":31,"locations":40,"responsibleParty":54,"collaborators":25,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":25,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University Hospital of Split","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Epidural group","ACTIVE_COMPARATOR","Epidural group will have an epidural catheter inserted in the T10\u002F11 or T11\u002F12 interspace using a midline approach. The epidural space will be identified by a loss of resistance to saline with a Tuohy 18G epidural needle. Subsequently, the epidural catheter will be inserted 4-6 cm into the epidural space and a test-dose of 2% lidocaine, 50 mg, to detect intrathecal misplacement will be given. Epidural group will subsequently receive intraoperative intermittent epidural analgesia followed by postoperative continuous infusion of a levobupivacaine and fentanyl mixture.",[13],"Procedure: Epidural Analgesia",{"label":15,"type":16,"description":17,"interventionNames":18},"Spinal group","EXPERIMENTAL","In Spinal group, 25 G or 27 G pencil point needle, depending on the preference of the anesthesiologist, will be inserted at L2-L3 or L3-L4 intervertebral space and 300 μg of preservative-free morphine (Morphine Kalceks ®, Kalceks, AS, Riga, Latvija, 10mg\u002Fml) diluted with sterile saline to a volume of 3 mL will be injected intrathecally.",[19],"Drug: Intrathecal Morphine",[21,26],{"type":22,"name":23,"description":17,"armGroupLabels":24,"otherNames":25},"DRUG","Intrathecal Morphine",[15],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"PROCEDURE","Epidural Analgesia","Epidural analgesia with levobupivacaine and fentanyl mixture. For intraoperative intermittent analgesia, Epidural group will be given a loading dose of 5-10 milliliters of a mixture of 10 micrograms per milliliter (μg\u002FmL) of fentanyl (Fentanyl Piramal Critical Care, 50 mcg\u002Fml) and 0.25% levobupivacaine (Levobupivakain Kabi 5 mg\u002Fml), followed by intermittent 4-5 mL boluses as needed throughout the surgery. Postoperative continuous epidural analgesia in the epidural group will consist of 2 μg\u002FmL fentanyl added to 0.1 % levobupivacaine at the rate 5-8 mL\u002Fh during the first 24 hours after surgery.",[9],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Svjetlana Došenović, MD, PhD","CONTACT","+38521556180","sdosenovic@yahoo.com",{"name":38,"role":34,"phone":35,"phoneExt":25,"email":39},"Meri Mirčeta, MD","mircetameri@gmail.com",[41],{"facility":42,"status":43,"city":44,"state":25,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":25},"University hospital of Split","RECRUITING","Split","21000","Croatia","HR",{"type":49,"coordinates":50},"Point",[51,52],16.43915,43.50891,{"lat":52,"lon":51},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Meri Mirceta","Anesthesiologist, Doctor of Medicine (MD)","100588001","phase-4-intrathecal-morphine-versus-epidural-analgesia-for-open-colon-surgery-100588001",false,"NCT06935708","Intrathecal Morphine Versus Epidural Analgesia for Open Colon Surgery","Intrathecal Morphine Versus Thoracic Epidural Analgesia for Open Colorectal Cancer Surgery: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Male or female patients with colorectal carcinoma undergoing laparoscopic abdominal surgery aged 18-80 years, ASA classification I-III, Body Mass Index (BMI) 15-35 kg\u002Fm2.\n\nExclusion Criteria:\n\n* abnormal coagulation function, defined as prothrombin time or activated partial prothrombin time above standard laboratory values or an international normalised ratio (INR) ≥1.4; or receiving ongoing therapeutic anticoagulation,\n* thrombocytopenia, defined as a platelet count \\\u003C80×10 9 L-1,\n* pre-existing skin infection at the neuraxial anesthesia puncture site,\n* pre-existing neurologic deficit, including peripheral neuropathy,\n* patients with dementia or other medical condition that includes communication difficulties,\n* patients with bradycardia (pulse \\\u003C50\u002Fmin) or with conduction block (2nd or 3rd degree)\n* history of opioid abuse,\n* allergies to any of the drugs used in the study.\n\nAdditionally, patients converted from laparoscopy to laparotomy due to technical surgical issues, patients with postoperative surgical complications (need for revision) or if epidural catheter placement\u002Fspinal anesthesia is unsuccessful even after an attempt by a senior anesthesiologist will also be excluded.","ALL","18 Years","80 Years",{"count":69,"type":70},98,"ESTIMATED","INTERVENTIONAL",[73],"PHASE4","Effective pain management after abdominal surgery is essential for recovery. This study compares two pain relief methods-intrathecal morphine (a single spinal injection) and continuous epidural analgesia-for patients undergoing open colorectal cancer surgery.\n\nThe investigators expect intrathecal morphine to provide equal pain relief at rest 24 hours after surgery, while epidural analgesia may be more effective during movement. By 48 to 72 hours, both methods should offer similar pain control. The epidural group may require fewer additional pain medications but could experience more side effects, including a higher risk of low blood pressure and technical difficulties. Additionally, these patients may have a slightly longer hospital stay. In contrast, the intrathecal morphine group may have fewer overall side effects. Despite these differences, patient satisfaction, sleep quality, and recovery are expected to be similar in both groups.\n\nBy evaluating these methods, this study aims to determine the most effective and safe approach to post-surgical pain management, improving comfort and recovery outcomes for patients.",[76,77,78],"Colorectal Carcinoma","Analgesia, Postoperative","Laparotomy",[80,81,82,83,84],"postoperative pain","analgesia","epidural","intrathecal morphine","laparotomy","2025-04-18",{"date":87,"type":88},"2025-04-20","ACTUAL",{"date":90,"type":88},"2025-04-08",{"date":92,"type":70},"2026-11",{"name":56,"class":6},1]