[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654684":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":25,"studyPopulation":26,"armGroups":27,"interventions":33,"overallOfficials":21,"centralContacts":39,"locations":45,"responsibleParty":62,"collaborators":66,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":21,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":81,"studyType":82,"phases":21,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":94,"whyStopped":21,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Malaya","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Rescue Analgesic Administration Events During the First 48 Hours After Abdominal Surgery","The number and timing of successful rescue analgesic events following elective abdominal surgery. A rescue analgesic event is defined as each successful patient-controlled analgesia (PCA) activation resulting in intravenous morphine delivery. The repeated occurrence and timing of rescue analgesic events will be analysed using repeated time-to-event modelling to characterise postoperative analgesic requirements.","Up to 48 hours after completion of surgery",[14,18],{"measure":15,"description":16,"timeFrame":17},"Postoperative Pain Scores","Pain intensity measured using the Numerical Rating Scale (NRS; 0-10) at predefined postoperative time points, including before and after rescue analgesic administration.","At PACU arrival\u002F every 15 minutes during PACU stay\u002F every 4 hours up to 48 hours after surgery",{"measure":19,"description":20,"timeFrame":12},"Morphine Exposure and Relationship With Rescue Analgesic Hazard","Relationship between predicted morphine plasma concentration derived from individual dosing histories and the hazard of subsequent rescue analgesic administration.",null,{"allocation":21,"interventionModel":21,"interventionModelDescription":21,"primaryPurpose":21,"observationalModel":23,"timePerspective":24,"maskingInfo":21},"COHORT","PROSPECTIVE","Postoperative pain remains a significant clinical challenge following abdominal surgery. Although multimodal analgesic strategies are widely implemented, many patients continue to experience moderate-to-severe pain during the early postoperative period and require repeated rescue analgesic administration. Current approaches to evaluate postoperative analgesic requirements often rely on total opioid consumption or time to first rescue analgesia. However, these methods may not fully capture the dynamic and repeated nature of postoperative pain and analgesic demand.\n\nThis study aims to develop a predictive model to characterise postoperative analgesic requirements in adults undergoing elective abdominal surgery. The study will use repeated time-to-event pharmacokinetic-pharmacodynamic modelling to analyse the timing and pattern of rescue morphine administration during the first 48 hours after surgery.\n\nThis is a prospective observational cohort study involving adult patients undergoing elective open or laparoscopic abdominal surgery under general anaesthesia. Participants will receive standard postoperative analgesic management according to routine clinical practice. No changes to clinical care will be introduced as part of the study.\n\nData collected will include patient demographics, surgical characteristics, anaesthetic details, postoperative pain scores, and analgesic administration records. Rescue analgesic events will be captured from patient-controlled analgesia (PCA) device records, including the timing and dose of successful morphine administrations. Individual morphine exposure will be estimated using documented dosing histories and published population pharmacokinetic parameters.\n\nThe collected data will be analysed using repeated time-to-event pharmacokinetic-pharmacodynamic modelling. The model will evaluate factors influencing the likelihood of requiring rescue analgesia over time, including temporal patterns, circadian effects, morphine exposure, and patient or surgical characteristics. Model performance will be assessed using simulation-based evaluation methods, including predictive checks and bootstrap analysis.\n\nThe expected outcome of this study is the development of a validated predictive framework for postoperative analgesic requirements after abdominal surgery. This model may provide a foundation for future personalised analgesic strategies, allowing earlier identification of patients at higher risk of inadequate pain control and supporting safer, more effective postoperative pain management.","Adults undergoing elective abdominal surgery under general anaesthesia will be enrolled in this prospective observational cohort study. The study population represents patients experiencing the early postoperative recovery phase, where pain trajectories and analgesic requirements vary substantially between individuals. Participants will be observed during the first 48 hours after surgery to characterise patterns of rescue analgesic use and postoperative pain.\n\nThe study aims to develop a predictive model of postoperative analgesic requirements by integrating analgesic administration patterns with patient and surgical characteristics. The findings will support a better understanding of individual variability in postoperative pain management and provide a foundation for future personalised analgesic strategies.",[28],{"label":29,"type":21,"description":30,"interventionNames":31},"Adult Patients Undergoing Elective Abdominal Surgery","Adult patients aged 18-75 years undergoing elective open or laparoscopic abdominal surgery under general anaesthesia will be enrolled in this prospective observational cohort. Participants will receive standard postoperative analgesic management according to routine clinical practice. Rescue analgesia will be provided using intravenous morphine via patient-controlled analgesia (PCA), and the timing and dose of successful analgesic administrations will be recorded during the first 48 hours after surgery. Patient demographics, surgical characteristics, pain scores, and analgesic administration data will be collected to develop a predictive model of postoperative analgesic requirements.",[32],"Drug: Intravenous Morphine Patient-Controlled Analgesia",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":21},"DRUG","Intravenous Morphine Patient-Controlled Analgesia","Participants will receive intravenous morphine via patient-controlled analgesia (PCA) as part of standard postoperative analgesic management following elective abdominal surgery. The study does not assign or modify analgesic treatment. Morphine PCA usage, including timing and dose of successful administrations, will be recorded to characterise postoperative analgesic requirements using repeated time-to-event modelling.",[29],[40],{"name":41,"role":42,"phone":43,"phoneExt":21,"email":44},"Tsyr Xiang Teoh, Master of Anaesthesiology","CONTACT","+603-79494422","teohtx@um.edu.my",[46],{"facility":47,"status":21,"city":48,"state":21,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Universiti Malaya Medical Centre","Kuala Lumpur","59100","Malaysia","MY",{"type":53,"coordinates":54},"Point",[55,56],101.68653,3.1412,{"lat":56,"lon":55},[59],{"name":60,"role":42,"phone":43,"phoneExt":21,"email":61},"SOOK HUI CHAW, PHD","sh_chaw@um.edu.my",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"SPONSOR_INVESTIGATOR","Chaw Sook Hui","Associate Professor of Anaesthesiology",[67],{"name":5,"class":6},"100654684","a-predictive-model-for-postoperative-analgesic-requirements-after-abdominal-surgery-100654684",false,"NCT07803575","A Predictive Model for Postoperative Analgesic Requirements After Abdominal Surgery","Quantitative Analysis of Postoperative Analgesia Following Abdominal Surgery Using Repeated Time-to-Event Modelling of Rescue Analgesic Administration","Inclusion Criteria:\n\n* Adult patients aged 18-75 years\n* American Society of Anesthesiologists (ASA) physical status I-III\n* Elective open or laparoscopic abdominal surgery under general anaesthesia\n* Expected postoperative ward or high-dependency unit (HDU) stay of ≥ 48 hours\n* Ability to provide written informed consent in Bahasa Malaysia or English\n* Ability to comprehend and self-report pain using the Numerical Rating Scale (NRS, 0-10)\n\nExclusion Criteria:\n\n* Chronic opioid therapy, defined as regular opioid use for ≥ 4 weeks prior to surgery\n* Severe hepatic impairment (Child-Pugh Class B or C) or severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²)\n* Known allergy or hypersensitivity to morphine or any opioid analgesic\n* Cognitive impairment (documented diagnosis of dementia or delirium), language barrier, or communication deficit precluding reliable NRS self-report\n* Documented history of substance use disorder (including opioid use disorder)\n* Withdrawal of informed consent at any point","ALL","18 Years","75 Years",{"count":79,"type":80},65,"ESTIMATED","2 Days","OBSERVATIONAL","Postoperative pain remains a common challenge after abdominal surgery despite the use of standard multimodal pain management strategies. Poorly controlled pain can delay recovery, limit early mobilisation, reduce patient comfort, and increase the risk of longer-term pain problems.\n\nThis study aims to develop a predictive model to better understand and anticipate patients' postoperative pain relief needs after abdominal surgery. The study will observe adults undergoing elective abdominal surgery and collect information on their pain scores, pain medication use, surgical characteristics, and recovery during the first 48 hours after surgery.\n\nParticipants will receive standard postoperative pain management according to usual clinical practice. The study will analyse patterns of rescue pain medication use, including when and how often additional pain relief is required after surgery. The collected information will be used to develop a model that can predict factors associated with increased pain medication requirements.\n\nThe goal of this research is to improve understanding of individual differences in postoperative pain and provide a foundation for more personalised pain management strategies in the future. The findings may help healthcare providers identify patients who are more likely to require additional pain relief and support the development of safer and more effective approaches to postoperative pain control.",[85,86,87,88],"Postoperative Pain","Postoperative Analgesia","Opioid Analgesic Requirement","Pain Management After Abdominal Surgery",[85,86,90,91,92,93],"Patient-Controlled Analgesia","Repeated Time-to-Event Modelling","Pharmacokinetic-Pharmacodynamic Modelling","Model-Informed Precision Dosing","NOT_YET_RECRUITING","2026-09-01",{"date":97,"type":98},"2026-09-03","ACTUAL",{"date":100,"type":80},"2027-01",{"date":102,"type":80},"2028-06",{"name":64,"class":6},1]