[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583840":3},{"organization":4,"outcomesModule":7,"designInfo":85,"detailedDescription":92,"studyPopulation":66,"armGroups":93,"interventions":106,"overallOfficials":66,"centralContacts":117,"locations":126,"responsibleParty":139,"collaborators":66,"id":143,"slug":66,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":66,"eligibilityCriteria":148,"healthyVolunteers":144,"sex":149,"minAge":150,"maxAge":151,"enrollmentInfo":152,"targetDuration":66,"studyType":155,"phases":156,"briefSummary":158,"conditions":159,"keywords":164,"overallStatus":171,"whyStopped":66,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},{"fullName":5,"class":6},"University Hospital of Split","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":66},[9],{"measure":10,"description":11,"timeFrame":12},"Pain intensity at rest 24 hours after surgery.","Level of pain intensity will be validated using Numeric Rating Scale ranging from 0-10.","24 hours",[14,18,22,26,30,34,36,40,44,48,52,56,60,64,67,70,73,77,81],{"measure":15,"description":16,"timeFrame":17},"Pain scores at rest and during movement at 1, 3, 6, 48, and 72 hours, and during movement at 24 h after surgery","Numeric Rating Scale","1, 3, 6, 24, 48, and 72 hours after surgery",{"measure":19,"description":20,"timeFrame":21},"Intraoperative use of fentanyl.","Total amount of administered fentanyl in mg.","For the duration of surgery.",{"measure":23,"description":24,"timeFrame":25},"Time to the first request for rescue analgesia.","Measured in minutes.","From the time of the surgery until the time to the first request for rescue analgesia (up to 3 days after the surgery)",{"measure":27,"description":28,"timeFrame":29},"Consumption of tramadol and metamizole.","Measured in mg.","Total amount of tramadol and metamizole within 72 hours after surgery.",{"measure":31,"description":32,"timeFrame":33},"Patient satisfaction","Measured with a 5-point Likert scale.","24, 48, and 72 hours after surgery",{"measure":35,"description":32,"timeFrame":33},"Quality of sleep.",{"measure":37,"description":38,"timeFrame":39},"Quality of Recovery","Measured with a 15-item Quality of Recovery 15 (QoR-15) scale.","72 hours after surgery",{"measure":41,"description":42,"timeFrame":43},"Length of stay (LOS) in HDU (high dependency unit)","Time to ward discharge in hours.","From the time of the admission to HDU until ward discharge (up to 30 days)",{"measure":45,"description":46,"timeFrame":47},"Length of hospital stay","Time from surgery to hospital discharge in days.","Form the day of surgery until hospital discharge (up to 90 days)",{"measure":49,"description":50,"timeFrame":51},"Time to ambulation","Measured in hours, defined as the patient independently getting out of bed.","From the end of surgery until patient ambulation (up to 30 days)",{"measure":53,"description":54,"timeFrame":55},"Time to gastro-intestinal recovery","First stool or flatus after surgery measured in hours, time to oral intake","From the end of surgery until the first documented stool, flatus or oral intake (up to 3 days)",{"measure":57,"description":58,"timeFrame":59},"Sedation score","Measured with a Ramsay sedation scale (1-6)","After extubation and 24 hours after surgery.",{"measure":61,"description":62,"timeFrame":63},"Incidence of respiratory depression","Respiratory rate \\\u003C8 \u002Fmin or need for assisted ventilation.","Within 24 hours after surgery.",{"measure":65,"description":66,"timeFrame":63},"Incidence of nausea or vomiting",null,{"measure":68,"description":69,"timeFrame":63},"Incidence of shivering, pruritus, hypotension, bradycardia.","Hypotension defined as systolic blood pressure less than 90 mmHg or diastolic less than 50 mmHg, mean arterial pressure \\\u003C 60 mmHg, or decline \\>20% from baseline, and bradycardia defined as heart rate \\\u003C50\u002Fmin.",{"measure":71,"description":66,"timeFrame":72},"Incidence of post-dural puncture headache","Within 72 hours after surgery.",{"measure":74,"description":75,"timeFrame":76},"Incidence of technique failure","Need to convert to a second analgesic technique due to multiple reasons, e.g., inability to perform spinal puncture, inability to insert an epidural catheter, inadequate analgesia, epidural catheter malfunction, or dislodgement.","Perioperative",{"measure":78,"description":79,"timeFrame":80},"Potoperative complications","Postoperative complications will be classified according to the Clavien Dindo Classification (1, 2, 3 a, 3 b, 4 a, 4 b, 5).","Until hospital discharge (up to 90 days)",{"measure":82,"description":83,"timeFrame":84},"Readmission rate","Readmission is defined as patient admission related to surgical procedure within 30 days after initial discharge.","Within 30 days after surgery",{"allocation":86,"interventionModel":87,"interventionModelDescription":66,"primaryPurpose":88,"observationalModel":66,"timePerspective":66,"maskingInfo":89},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":90,"maskingDescription":91,"whoMasked":66},"NONE","The person performing the data analysis will be blinded to treatment allocation.","Participants of this study will be randomly selected adult patients with colorectal carcinoma undergoing laparoscopic colorectal resection who fulfill the inclusion criteria and sign the informed consent for participation.\n\nThis sample represents the population of adult patients with colorectal cancer undergoing laparoscopic surgery by ERAS protocol in a tertiary hospital of a high-developed country.\n\nPatients will be randomly divided into Epidural group (E group) or Spinal group (S group) and will receive different intraoperative and postoperative analgesia plans.\n\nE group will be treated as a control group. Patients in S group will receive intrathecal morphine as analgesia for colorectal resection and it will be treated as experimental group.\n\nAnesthesia induction and maintenance will be the same in both groups. The primary outcome is pain intensity at rest measured with the Numeric Rating Scale (0 = no pain and 10 = worst pain) 24 hours after surgery. Secondary outcome measures are analgesic consumption, time to rescue analgesia, patient satisfaction, quality of sleep, length of hospital stay, time to return of bowel function, and adverse events (such as respiratory depression, nausea or vomiting, hypotension and bradycardia).\n\nPostoperative continuous epidural analgesia in the E 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.\n\nAdditional epidural boluses will be allowed by the nursing staff for pain Numerical Rating Scale (NRS)≥4.\n\nBoth groups will receive standard multimodal analgesic protocol with the goal of postoperative pain NRS\\\u003C4: intravenous (iv) paracetamol 1 g up to 4 times per day and iv metamizole 2.5 g up to 2 times per day and tramadol 50-100 mg iv as needed. In the control group, epidural analgesia will be used for postoperative pain relief for up to 24 h. An algorithm of postoperative rescue analgesia is established for each group.\n\nRescue antiemetics will be given in case of postoperative nausea and vomiting (PONV): metoclopramide 10 mg iv up to 3 times per day and granisetron 1 mg iv up to 3 times per day.\n\nSevere pruritus will be treated with antihistamines or naloxone 40 mcg iv.",[94,100],{"label":95,"type":96,"description":97,"interventionNames":98},"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.\n\nEpidural group will subsequently receive intraoperative intermittent epidural analgesia followed by postoperative continuous infusion of a levobupivacaine and fentanyl mixture.",[99],"Procedure: Epidural Analgesia",{"label":101,"type":102,"description":103,"interventionNames":104},"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.",[105],"Drug: Intrathecal Morphine",[107,112],{"type":108,"name":109,"description":110,"armGroupLabels":111,"otherNames":66},"DRUG","Intrathecal Morphine","In this group, 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.",[101],{"type":113,"name":114,"description":115,"armGroupLabels":116,"otherNames":66},"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.\n\nPostoperative 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.",[95],[118,123],{"name":119,"role":120,"phone":121,"phoneExt":66,"email":122},"Svjetlana Došenović, MD, PhD","CONTACT","+38521556180","sdosenovic@yahoo.com",{"name":124,"role":120,"phone":121,"phoneExt":66,"email":125},"Meri Mirčeta, MD","mircetameri@gmail.com",[127],{"facility":128,"status":66,"city":129,"state":66,"zip":130,"country":131,"countryCode":132,"cosmosGeoPoint":133,"geoPoint":138,"contacts":66},"University Hospital Split","Split","21000","Croatia","HR",{"type":134,"coordinates":135},"Point",[136,137],16.43915,43.50891,{"lat":137,"lon":136},{"type":140,"investigatorFullName":141,"investigatorTitle":142,"investigatorAffiliation":5,"oldNameTitle":66,"oldOrganization":66},"SPONSOR_INVESTIGATOR","Meri Mirceta","Anesthesiologist, Doctor of Medicine (MD)","100583840",false,"NCT06881563","Intrathecal Morphine Versus Epidural Analgesia for Laparoscopic Colon Surgery","Intrathecal Morphine Versus Epidural Analgesia for Laparoscopic 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":153,"type":154},98,"ESTIMATED","INTERVENTIONAL",[157],"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 minimally invasive colorectal cancer surgery.\n\nThe investigators expect intrathecal morphine to provide better 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.",[160,161,162,163],"Postoperative Pain","Analgesia","Colorectal Cancer","Surgery",[165,166,167,168,169,170],"epidural","intrathecal morphine","laparoscopy","analgesia","colorectal cancer","postoperative pain","NOT_YET_RECRUITING","2025-03-17",{"date":174,"type":175},"2025-03-18","ACTUAL",{"date":177,"type":154},"2025-03",{"date":179,"type":154},"2026-08",{"name":141,"class":6},1]