[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658095":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":52,"studyPopulation":42,"armGroups":53,"interventions":65,"overallOfficials":75,"centralContacts":79,"locations":89,"responsibleParty":108,"collaborators":42,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":42,"eligibilityCriteria":117,"healthyVolunteers":113,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":42,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":131,"overallStatus":136,"whyStopped":42,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Bangladesh Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":42},[9],{"measure":10,"description":11,"timeFrame":12},"Total postoperative morphine consumption in miligram (mg)","Total morphine sulfate consumption in mg during the first 24 postoperative hours.","First 24 postoperative hours",[14,18,22,26,29,32,35,39],{"measure":15,"description":16,"timeFrame":17},"Postoperative Pain Intensity","Postoperative pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain, and 10 indicates the worst imaginable pain. Pain scores will be recorded at rest and during movement at predefined postoperative time points. The NRS pain scores will be compared between the dexmedetomidine and ketamine groups following total abdominal hysterectomy.","2, 4, 6, 12, and 24 hours after surgery",{"measure":19,"description":20,"timeFrame":21},"Time to First Rescue Analgesic Request","The time interval from completion of surgery to the first requirement of rescue analgesia (intravenous morphine sulfate) will be recorded and compared between the dexmedetomidine and ketamine groups. Rescue analgesia will be administered when the Numeric Rating Scale (NRS) pain score reaches ≥4.","First 24 hours after surgery",{"measure":23,"description":24,"timeFrame":25},"Heart Rate (HR)","Heart rate will be recorded before administration of the ultrasound-guided TAP block (baseline) and subsequently monitored after surgery. The changes in heart rate will be compared between the dexmedetomidine and ketamine groups to assess haemodynamic response following the intervention.","Baseline [before Tranversus Abdominis Plane (TAP) Block], and 2, 4, 6, 12, and 24 hours after surgery",{"measure":27,"description":28,"timeFrame":25},"Systolic Blood Pressure (SBP)","Systolic blood pressure will be measured before administration of the ultrasound-guided TAP block (baseline) and during the postoperative period. Changes in systolic blood pressure will be compared between the dexmedetomidine and ketamine groups.",{"measure":30,"description":31,"timeFrame":25},"Diastolic Blood Pressure (DBP)","Diastolic blood pressure will be measured before administration of the ultrasound-guided TAP block (baseline) and during postoperative follow-up. Changes in diastolic blood pressure will be compared between the dexmedetomidine and ketamine groups.",{"measure":33,"description":34,"timeFrame":25},"Mean Arterial Pressure (MAP)","Mean arterial pressure will be recorded before administration of the ultrasound-guided TAP block (baseline) and during postoperative follow-up. Changes in mean arterial pressure will be compared between the dexmedetomidine and ketamine groups to assess haemodynamic stability.",{"measure":36,"description":37,"timeFrame":38},"Postoperative Nausea and Vomiting (PONV)","The occurrence of postoperative nausea and vomiting will be assessed and compared between the dexmedetomidine and ketamine groups. Data regarding postoperative nausea and vomiting episodes will be collected from the postoperative record sheet after completion of the 24-hour postoperative observation period.","Within 24 hours after surgery",{"measure":40,"description":41,"timeFrame":17},"Sedation Level (Ramsay Sedation Score)","Postoperative sedation level will be assessed using the Ramsay Sedation Score and compared between the dexmedetomidine and ketamine groups. The Ramsay Sedation Score is a 6-point ordinal scale ranging from 1 to 6, where 1 indicates an anxious, agitated, or restless patient and 6 indicates no response to stimulation. Higher scores indicate a greater level of sedation. The score will be recorded during the postoperative observation period.",null,{"allocation":44,"interventionModel":45,"interventionModelDescription":42,"primaryPurpose":46,"observationalModel":42,"timePerspective":42,"maskingInfo":47},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":48,"maskingDescription":42,"whoMasked":49},"DOUBLE",[50,51],"PARTICIPANT","OUTCOMES_ASSESSOR","Postoperative pain following total abdominal hysterectomy is influenced by both somatic and visceral components. The abdominal wall incision contributes significantly to somatic pain, while pelvic tissue manipulation contributes to visceral pain. Effective perioperative analgesia is essential to facilitate recovery and reduce opioid-related adverse effects.\n\nThe transversus abdominis plane (TAP) block is an established regional anaesthesia technique that provides analgesia by depositing local anaesthetic within the fascial plane between the internal oblique and transversus abdominis muscles, thereby reducing transmission of nociceptive signals from the abdominal wall. However, the duration of analgesia achieved with local anaesthetic alone may be limited, leading to interest in the use of adjuvant medications to enhance and prolong analgesic effects.\n\nDexmedetomidine and ketamine have different pharmacological mechanisms that may contribute to improved analgesia when combined with local anaesthetics. Dexmedetomidine, an α2-adrenergic receptor agonist, may enhance peripheral nerve block effects through modulation of neuronal excitability and nociceptive transmission. Ketamine, through NMDA receptor antagonism, may reduce central sensitization and hyperalgesia. Although both agents have demonstrated analgesic benefits in regional anaesthesia, comparative evidence regarding their relative effectiveness as adjuvants in TAP block for patients undergoing total abdominal hysterectomy remains limited.\n\nThis study is designed to generate comparative evidence regarding the analgesic efficacy and safety profile of these two commonly used adjuvant agents when administered with bupivacaine in ultrasound-guided TAP block. The findings may contribute to optimizing multimodal analgesic strategies and improving postoperative recovery after major gynaecological surgery",[54,60],{"label":55,"type":56,"description":57,"interventionNames":58},"Bupi-Dex","ACTIVE_COMPARATOR","Participants allocated to this group will receive an ultrasound-guided bilateral Transversus Abdominis Plane (TAP) block using bupivacaine combined with dexmedetomidine as an adjuvant.",[59],"Drug: TAP block using Dexmedetomidine & Bupivacaine",{"label":61,"type":56,"description":62,"interventionNames":63},"Bupi-Ket","Participants allocated to this group will receive an ultrasound-guided bilateral Transversus Abdominis Plane (TAP) block with bupivacaine and ketamine hydrochloride as an adjuvant.",[64],"Drug: TAP block using Ketamine Hydrochloride and Bupivacaine",[66,71],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":42},"DRUG","TAP block using Dexmedetomidine & Bupivacaine","The study intervention consists of administering 0.25% bupivacaine combined with dexmedetomidine 0.5 microgram\u002Fkg as an adjuvant.",[55],{"type":67,"name":72,"description":73,"armGroupLabels":74,"otherNames":42},"TAP block using Ketamine Hydrochloride and Bupivacaine","Ketamine hydrochloride 1 mg\u002Fkg administered as an adjuvant with 0.25% bupivacaine during ultrasound-guided bilateral TAP block.",[61],[76],{"name":77,"affiliation":5,"role":78},"Md Shafiqul M Islam","STUDY_DIRECTOR",[80,85],{"name":81,"role":82,"phone":83,"phoneExt":42,"email":84},"Kazi Mahzabin Arin, MD","CONTACT","+8801754057689","kazimahzabinarin@bmu.ac.bd",{"name":86,"role":82,"phone":87,"phoneExt":42,"email":88},"Md Shafiqul Islam, MD","+8801712116650","mdsislam@bsmmu.edu.bd",[90],{"facility":5,"status":42,"city":91,"state":42,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"Dhaka","1000","Bangladesh","BD",{"type":96,"coordinates":97},"Point",[98,99],90.40744,23.7104,{"lat":99,"lon":98},[102,106],{"name":103,"role":82,"phone":104,"phoneExt":42,"email":105},"Susmita Ghosh","+8801704557371","susmitaghosh300595@gmail.com",{"name":103,"role":107,"phone":42,"phoneExt":42,"email":42},"PRINCIPAL_INVESTIGATOR",{"type":107,"investigatorFullName":109,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Kazi Mahzabin Arin","Assistant Professor","100658095","phase-4-dexmedetomidine-versus-ketamine-in-tap-block-for-postoperative-analgesia-after-total-abdominal-hysterectomy-100658095",false,"NCT07845643","Dexmedetomidine Versus Ketamine in TAP Block for Postoperative Analgesia After Total Abdominal Hysterectomy","Dexmedetomidine Versus Ketamine as an Adjuvant to Bupivacaine in Ultrasound-Guided Transversus Abdominis Plane Block for Postoperative Analgesia Following Total Abdominal Hysterectomy","Inclusion Criteria:\n\n* Patients scheduled for elective total abdominal hysterectomy\n* ASA physical status I-II\n* Age 25-60 years\n\nExclusion Criteria:\n\n* Allergy to local anaesthetics\n* Patient refusal\n* Local infection\u002Finflammation at block site\n* Anatomical deformity\n* Coagulopathy or bleeding disorder\n* Chronic pain syndrome\n* Chronic opioid consumption (\\>2 weeks)\n* Severe cardiac, hepatic, renal, or psychiatric disorders","FEMALE","25 Years","60 Years",{"count":122,"type":123},64,"ESTIMATED","INTERVENTIONAL",[126],"PHASE4","Total abdominal hysterectomy is associated with significant postoperative pain due to abdominal wall incision and tissue manipulation. Effective pain management after surgery helps improve patient comfort, early mobilization, and recovery while reducing the need for opioid medications and their related side effects.\n\nThe transversus abdominis plane (TAP) block is a regional anaesthesia technique that provides pain relief by blocking sensory nerves supplying the abdominal wall. However, the duration of analgesia provided by local anaesthetic alone may be limited. Adding adjuvant drugs such as dexmedetomidine or ketamine may enhance and prolong the analgesic effect.\n\nThis randomized controlled trial aims to compare the effectiveness of dexmedetomidine and ketamine as adjuvants to bupivacaine in ultrasound-guided bilateral TAP block for postoperative pain management following total abdominal hysterectomy.\n\nParticipants undergoing elective total abdominal hysterectomy will be randomly assigned to receive either bupivacaine with dexmedetomidine or bupivacaine with ketamine during TAP block. Postoperative pain intensity, morphine consumption, time to first rescue analgesia, haemodynamic changes, sedation level and postoperative nausea and vomiting will be assessed during the first 24 hours after surgery.\n\nThe findings of this study may help determine which adjuvant provides better postoperative analgesia when combined with bupivacaine for TAP block in patients undergoing total abdominal hysterectomy.",[129,130],"Postoperative Pain","Total Abdominal Hysterectomy",[130,132,133,134,135],"Dexmedetomidine","Ketamine","Postoperative analgesia","Transversus abdominis plane block","NOT_YET_RECRUITING","2026-09-28",{"date":139,"type":140},"2026-10-01","ACTUAL",{"date":139,"type":123},{"date":143,"type":123},"2027-04-30",{"name":5,"class":6},1]