[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657584":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":28,"studyPopulation":18,"armGroups":29,"interventions":41,"overallOfficials":18,"centralContacts":51,"locations":60,"responsibleParty":80,"collaborators":18,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":18,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":18,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":18,"overallStatus":63,"whyStopped":18,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Pakistan Institute of Medical Sciences","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Maximum fall in Mean Arterial Pressure","Maximum decrease in mean arterial pressure (MAP) from the pre-induction baseline value recorded during the intraoperative period, measured using automated oscillometric non-invasive blood pressure monitoring. MAP will be recorded at predefined intraoperative intervals, and the greatest fall from baseline will be reported in mmHg.","Peri-operative from From induction of anesthesia until completion of surgery",[14],{"measure":15,"description":16,"timeFrame":17},"Conversion rate to General Anesthesia","This will be the number of patients requiring conversion of either spinal or saddle anesthesia to general anesthesia intraoperatively due to block failure","Peri-operative",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":24,"maskingDescription":18,"whoMasked":25},"DOUBLE",[26,27],"PARTICIPANT","OUTCOMES_ASSESSOR","After informed consent, patient fulfilling the inclusion criteria will be enrolled in the study. All patients will be brought into OR and standard ASA monitoring will be attached and baseline hemodynamics will be recorded. Patients will be randomly divided into two groups using computer generated random numbers. Group N patients will receive spinal anesthesia with 15mg of hyperbaric bupivacaine at L3 L4 level using 25G spinal needle while group S will receive saddle block with 15 mg of hyperbaric bupivacaine at L3 L4 level using 25 G spinal needle. Those receiving spinal anesthesia will be made to lie down immediately after intrathecal drug administration while those who received saddle block will be made to sit for five minutes and then will be made to lie down. Level of block will be assessed. Those having block less than T10 dermatome will be made excluded from the study. Intraoperatively hemodynamics will be monitored at 3 minutes interval. Any fall in blood pressure by more than 20% from baseline or fall in MAP to less than 65 mm of Hg will be noted and treated with Phenylephrine IV bolus of 50-100 Mcg. Intraoperatively any conversion to general anesthesia will also be noted.",[30,36],{"label":31,"type":32,"description":33,"interventionNames":34},"Group Saddle","ACTIVE_COMPARATOR","Patients in this group will receive Saddle block",[35],"Drug: Saddle block",{"label":37,"type":32,"description":38,"interventionNames":39},"Group Spinal anesthesia","Patients in this group will receive Spinal anesthesia",[40],"Drug: Spinal Anesthesia (bupivacaine)",[42,47],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":18},"DRUG","Saddle block","Patients will receive with 15 mg of hyperbaric bupivacaine at L3 L4 level using 25 G spinal needle and will be made to sit for 5 minutes before lying down",[31],{"type":43,"name":48,"description":49,"armGroupLabels":50,"otherNames":18},"Spinal Anesthesia (bupivacaine)","Patients will receive spinal anesthesia with 15mg of hyperbaric bupivacaine at L3 L4 level using 25G spinal needle and will be immediately made to lie down",[37],[52,57],{"name":53,"role":54,"phone":55,"phoneExt":18,"email":56},"Department of Anesthesia Principal Investigator, MBBS,FCPS","CONTACT","+92-333-5236956","departmentofanesthesiapims@gmail.com",{"name":58,"role":54,"phone":55,"phoneExt":18,"email":59},"Muhammad Haroon Anwar, MBBS,FCPS","haroonanwar22@gmail.com",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Deparmtent of Anesthesia and Critical Care Medicine, Pakistan Institute of Medical Sciences","RECRUITING","Islamabad","Federal","44000","Pakistan","PK",{"type":70,"coordinates":71},"Point",[72,73],73.04329,33.72148,{"lat":73,"lon":72},[76],{"name":77,"role":54,"phone":78,"phoneExt":18,"email":79},"Naheed Fatima Head of Department, MBBS,FCPS,MHPE","+92 300 5236655","naheedfk73@gmail.com",{"type":81,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Department of Anesthesia","Principal Investigator","100657584","phase-4-modified-saddle-block-vs-spinal-anesthesia-for-turp-100657584",false,"NCT07841184","Modified Saddle Block vs Spinal Anesthesia for TURP","Comparison of Modified Saddle Block With Spinal Anesthesia Among Patients Undergoing Transurethral Resection of Prostate Cancer; A Randomized Control Trial at a Tertiary Care Hospital","Inclusion Criteria:\n\n* Age 40- 90 years\n* Elective TURP surgery under Neuraxial Anesthesia\n* ASA class I and II\n\nExclusion Criteria:\n\n* Contraindication to Neuraxial anesthesia\n* Allergic to study medications\n* Lack of consent",true,"MALE","40 Years","90 Years",{"count":96,"type":97},60,"ESTIMATED","INTERVENTIONAL",[100],"PHASE4","After obtaining informed consent, eligible patients will be enrolled in the study. Standard monitoring will be applied in the operating room and baseline blood pressure and heart rate will be recorded. Participants will be randomly assigned to receive either spinal anesthesia or a modified saddle block using hyperbaric bupivacaine administered in the lower back. The position of the patient after injection will differ according to the assigned anesthetic technique. The level of numbness produced by the anesthesia will be assessed, and patients with inadequate anesthesia will be excluded. Blood pressure and heart rate will be monitored regularly during surgery. Any significant decrease in blood pressure will be treated with intravenous phenylephrine. Any need to change to general anesthesia during the procedure will also be recorded.",[103,104,105,106],"TURP(Transurethral Resection of Prostate)","Spinal Anesthesia","Saddle Block Anesthesia","Hypotension During Surgery","2026-09-24",{"date":109,"type":110},"2026-09-25","ACTUAL",{"date":112,"type":97},"2026-08-25",{"date":114,"type":97},"2026-12-31",{"name":5,"class":6},1]