[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"patients-undergoing-major-laparoscopic-abdominal-surgery\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:patients-undergoing-major-laparoscopic-abdominal-surgery":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100567345","phase-4-intrathecal-morphine-for-postoperative-analgesia-in-major-laparoscopic-abdominal-surgery-a-impact-scope-trial-100567345",false,"NCT06666985","Intrathecal Morphine for Postoperative Analgesia in Major Laparoscopic Abdominal Surgery, a IMPACT-Scope Trial","Intrathecal Morphine for Postoperative Analgesia in Major Laparoscopic Abdominal Surgery (IMPACT-Scope): a Randomised, Sham-controlled, Blinded, Multicentre Clinical Trial","IMPACT-Scope","Inclusion criteria:\n\n* Age 18 years or over AND able to give informed consent (with interpreters provided where necessary)\n* Elective (i.e., planned) laparoscopic or robotic abdominal surgery within one or more of the following specialties:\n\n  * Colorectal\n  * Gynaecology\n  * Hepato-biliary (including pancreatic surgery)\n  * Upper gastrointestinal\n  * Urology\u002FRenal\n* Anticipated duration of surgery ≥ 2 hours (from knife-to-skin to end of wound closure)\n* Anticipated hospital stay ≥ 24 hours (from the end of surgery)\n\nExclusion criteria:\n\n* Allergy to study drugs\n* Anatomical factors making intrathecal injection impossible\n* Anticipated requirement for postoperative invasive ventilation\n* American Society of Anesthesiologists (ASA) Score \\\u003CIV\n* Coagulopathies (i.e. INR\\>1.3 and\u002For platelet count\\\u003C100×10\\^9\u002FL)\n* Cognitive impairment leading to inability to complete the study processes and questionnaires\n* Drugs affecting coagulation (except aspirin), which have not been suitably and timely paused preoperatively\n* Infection near the planned site of intrathecal injection\n* Ongoing sepsis\n* Patients previously included in the trial and who need to return to theatre for a new abdominal surgery\n* Pregnancy or breast feeding","ALL","18 Years",{"count":20,"type":21},700,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The goal of this clinical trial is to learn the clinical and cost effectiveness of intrathecal morphine (ITM) in addition to usual care as a postoperative pain relief strategy following major laparoscopic abdominal surgery compared with current usual care. The main questions it aims to answer are:\n\nAn enhanced analgesic technique, consisting of ITM in addition to usual care , improves the postoperative quality of recovery at day 1 after surgery by at least 6 points on the 15-item quality of recovery questionnaire (QoR-15) compared to usual care alone, in patients undergoing major laparoscopic abdominal surgery?\n\nResearchers will compare ITM + Usual care to Sham ITM + Usual Care (The sham ITM mimics the ITM procedure, but the dura is not breached) to see if ITM works to postoperative pain relief.\n\nParticipants will:\n\nReceive ITM + Usual care or Sham ITM + Usual care on surgery day Have interview with outcome assessors and complete the CRFs on the day of surgery, postoperative day 1, day 2, day 3 and up to postoperative day 30",[27],"Patients Undergoing Major Laparoscopic Abdominal Surgery",[29,30,31],"laparoscopic surgery","intrathecal morphine","quality of recovery","RECRUITING","2025-11-19",{"date":35,"type":36},"2025-11-24","ACTUAL",{"date":38,"type":36},"2024-12-16",{"date":40,"type":21},"2026-12-31",{"name":42,"class":43},"First Affiliated Hospital, Sun Yat-Sen University","OTHER"]