[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567345":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":27,"locations":36,"responsibleParty":52,"collaborators":11,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":11,"enrollmentInfo":66,"targetDuration":11,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":39,"whyStopped":11,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"First Affiliated Hospital, Sun Yat-Sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ITM + Usual Care","EXPERIMENTAL",null,[13],"Drug: ITM + Usual Care",{"label":15,"type":16,"description":11,"interventionNames":17},"Sham ITM + Usual Care","SHAM_COMPARATOR",[18],"Drug: Sham ITM + Usual Care",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","The participants allocated to this group will receive ITM (Intrathecal Morphine) in addition to usual care with opioid-based PCA(Patient-Controlled Analgesia). ITM consists of an intrathecal injection of 300 micrograms (0.3mg) of preservative-free morphine.Usual care involves postoperative analgesia with opioid-based PCA without postoperative continuous infusion of opioids. No other drugs other than opioids are allowed in the PCA.",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"The sham ITM mimics the ITM procedure, but the dura is not breached.",[15],[28,33],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"Xia Feng","CONTACT","86-13688877856","fengxia@mail.sysu.edu.cn",{"name":34,"role":30,"phone":11,"phoneExt":11,"email":35},"Jiangtao Zhou","impact_scope@163.com",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":11,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"The First Affiliated Hospital of Sun Yat-sen University","RECRUITING","Guangzhou","Guangdong","China","CN",{"type":45,"coordinates":46},"Point",[47,48],113.25,23.11667,{"lat":48,"lon":47},[51],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Feng Xia","Professor","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":67,"type":68},700,"ESTIMATED","INTERVENTIONAL",[71],"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",[74],"Patients Undergoing Major Laparoscopic Abdominal Surgery",[76,77,78],"laparoscopic surgery","intrathecal morphine","quality of recovery","2025-11-19",{"date":81,"type":82},"2025-11-24","ACTUAL",{"date":84,"type":82},"2024-12-16",{"date":86,"type":68},"2026-12-31",{"name":5,"class":6},1]