[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601981":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":60,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":92,"overallStatus":97,"whyStopped":26,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Tribhuvan University Teaching Hospital, Institute Of Medicine.","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Dexmedetomidine Group (Group BD)","EXPERIMENTAL","Participants in this arm will receive 15 mg (3 mL) of 0.5% hyperbaric bupivacaine combined with 10 mcg (0.5 mL) of dexmedetomidine intrathecally. The total injected volume will be 3.5 mL.",[13],"Drug: Intervention 1: Intrathecal Dexmedetomidine with Bupivacaine",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2: Fentanyl Group (Group BF)","ACTIVE_COMPARATOR","Participants in this arm will receive 15 mg (3 mL) of 0.5% hyperbaric bupivacaine combined with 25 mcg (0.5 mL) of fentanyl intrathecally. The total injected volume will be 3.5 mL.",[19],"Drug: Intervention 2: Intrathecal Fentanyl with Bupivacaine",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Intervention 1: Intrathecal Dexmedetomidine with Bupivacaine","Intervention 1: Intrathecal Dexmedetomidine with Bupivacaine\n\nDetailed Description:\n\nThis intervention consists of a single intrathecal injection of 10 micrograms of dexmedetomidine combined with 15 mg (3 mL) of 0.5% hyperbaric bupivacaine, administered during spinal anaesthesia for lower limb surgery. The total volume administered is 3.5 mL. Dexmedetomidine is an alpha-2 non-opioid adjuvant used as a spinal adjuvant for enhancing analgesia",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Intervention 2: Intrathecal Fentanyl with Bupivacaine","This intervention consists of a single intrathecal injection of 25 micrograms of fentanyl combined with 15 mg (3 mL) of 0.5% hyperbaric bupivacaine, administered during spinal anesthesia for lower limb surgery. The total volume administered is 3.5 mL. Fentanyl is a lipophilic opioid commonly used as a spinal adjuvant for enhancing analgesia. This arm is being compared with dexmedetomidine to evaluate differences in POUR incidence, analgesic effectiveness, and side effect profiles.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Sujan Dhakal, MBBS,MD","CONTACT","+9779851325896","szndkl44@gmail.com",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Om Sai Pathibhara Hospital","Bhadrapur","Koshi","57200","Nepal","NP",{"type":46,"coordinates":47},"Point",[48,49],88.09436,26.54404,{"lat":49,"lon":48},[52,55,56,58],{"name":53,"role":34,"phone":54,"phoneExt":26,"email":36},"Om Sai Pathibhara hospital admin","023-453981",{"name":26,"role":34,"phone":26,"phoneExt":26,"email":36},{"name":33,"role":57,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"name":59,"role":57,"phone":26,"phoneExt":26,"email":26},"Sanjeev Kumar Sharma, MBBS,MD",{"type":57,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Sujan Dhakal, MD","Principal Investigator","100601981","phase-4-d-fab-pour-trial-dexmedetomidine-vs-fentanyl-as-adjuvants-to-bupivacaine-on-postoperative-urinary-retention-100601981",false,"NCT07117565","D-FAB-POUR Trial: Dexmedetomidine vs Fentanyl as Adjuvants to Bupivacaine on Postoperative Urinary Retention","Comparison of Intrathecal Dexmedetomidine Versus Intrathecal Fentanyl as Adjuvants to Bupivacaine on Post-Operative Urinary Retention in Lower Limb Surgery","D-FAB-POUR","Inclusion Criteria:\n\n* Adults aged 18 to 60 years\n* Scheduled for elective lower limb surgery under spinal anesthesia\n* Classified as American Society of Anesthesiologists (ASA) physical status II or III\n* Minimum height of 150 cm (to ensure uniform drug volume)\n* Able to understand the study procedures and provide written informed consent (in English or Nepali)\n\nExclusion Criteria:\n\n* Contraindications to spinal anesthesia (e.g., coagulopathy, infection at injection site, hemodynamic instability)\n* Known allergy or hypersensitivity to bupivacaine, fentanyl, or dexmedetomidine\n* Chronic pain conditions or long-term opioid use\n* Neurological, Cardiac, Renal, or uncontrolled diabetic conditions\n* Current treatment for prostatic pathology or use of alpha-2 blockers\n* Presence of a Foley's catheter preoperatively\n* Estimated surgical duration: \\>2.5 hours\n* Inability or unwillingness to provide informed consent",true,"ALL","18 Years","60 Years",{"count":76,"type":77},190,"ESTIMATED","INTERVENTIONAL",[80],"PHASE4","This study aims to compare two medications, dexmedetomidine and fentanyl, when used alongside a commonly used spinal anesthetic called bupivacaine in patients undergoing lower limb surgery. The main focus of the study is to see which combination causes fewer problems with urination after surgery - a condition known as postoperative urinary retention (POUR). POUR can lead to discomfort, delayed recovery, and a need for catheterization. Dexmedetomidine is a newer drug that may help reduce this problem compared to fentanyl, which is more commonly used but may increase the risk of urinary retention. This trial will help determine which medication combination provides better pain relief while reducing urinary side effects. The study is being conducted as a randomized, double-blind trial at a hospital in Nepal and will include 190 adult patients.\n\n\\-",[83,84,85,86,87,88,89,90,91],"Spinal Anesthesia","Postoperative Complications","Dexmedetomidine","Fentanyl","Anesthesia, Spinal","Bupivacaine","POUR","Orthopedic Surgery","Urinary Retention Postoperative",[93,94,95,85,86,96],"Postoperative urinary retention","Spinal anesthesia","Intrathecal adjuvants","Perioperative complications","NOT_YET_RECRUITING","2025-08-09",{"date":100,"type":101},"2025-08-12","ACTUAL",{"date":103,"type":77},"2025-09-15",{"date":105,"type":77},"2026-11-25",{"name":5,"class":6},1]