[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657577":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":16,"studyPopulation":16,"armGroups":38,"interventions":49,"overallOfficials":58,"centralContacts":62,"locations":71,"responsibleParty":87,"collaborators":16,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":16,"enrollmentInfo":100,"targetDuration":16,"studyType":103,"phases":104,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":114,"whyStopped":16,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"The University of Texas Health Science Center, Houston","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Change in pain as assessed by the visual analog scale (VAS)","Pain will be scored from 1-10 , higher number indicating more pain","4-6 hours post operation, postoperative day 1, postoperative day 3",[14,18,20,22,24,26],{"measure":15,"description":16,"timeFrame":17},"Change in level of pain control achieved as assessed by the amount of nonsteroidal anti-inflammatory drugs (NSAIDs) needed",null,"2-week and 6- week follow up",{"measure":19,"description":16,"timeFrame":17},"Change in level of pain control achieved as assessed by the frequency of NSAIDS needed",{"measure":21,"description":16,"timeFrame":17},"Change in level of pain control achieved as assessed by the amount of opioids needed",{"measure":23,"description":16,"timeFrame":17},"Change in level of pain control achieved as assessed by the frequency of opioids needed",{"measure":25,"description":16,"timeFrame":17},"Change in level of bleeding as assessed by the volume of blood loss reported by the surgeon",{"measure":27,"description":28,"timeFrame":17},"Change in presence of vaginal dehiscence","This will be categorically reported as a yes or no answer",{"allocation":30,"interventionModel":31,"interventionModelDescription":16,"primaryPurpose":32,"observationalModel":16,"timePerspective":16,"maskingInfo":33},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":34,"maskingDescription":16,"whoMasked":35},"DOUBLE",[36,37],"PARTICIPANT","OUTCOMES_ASSESSOR",[39,44],{"label":40,"type":41,"description":16,"interventionNames":42},"Combined Bupivacaine and Exparel","EXPERIMENTAL",[43],"Drug: Combined Bupivacaine and Exparel",{"label":45,"type":46,"description":16,"interventionNames":47},"Control","PLACEBO_COMPARATOR",[48],"Drug: Normal Saline (NS)",[50,54],{"type":51,"name":40,"description":52,"armGroupLabels":53,"otherNames":16},"DRUG","In addition to the Laparoscopic Transversus Abdominis Plane (TAP) Block, participants will receive 20 cc of a mixture of 40 cc of short term 0.25% bupivacaine hydrochloride and long term 20 mL of Exparel® (266 mg\u002F20 mL) mixed with 100cc of normal saline (total amount 160 cc) to the vaginal cuff using William's cystoscopy needle. The mixture will be infiltrated evenly at the uterosacral ligament with care (10 cc on each uterosacral ligament) taken to distribute the injection across the full length of the cuff at the end of the procedure.",[40],{"type":51,"name":55,"description":56,"armGroupLabels":57,"otherNames":16},"Normal Saline (NS)","In addition to the Laparoscopic Transversus Abdominis Plane (TAP) Block, participants will get will get vaginal cuff infiltration with 20 cc of injectable NS at the end of the procedure.",[45],[59],{"name":60,"affiliation":5,"role":61},"Asha B Bhalwal, MD","PRINCIPAL_INVESTIGATOR",[63,67],{"name":60,"role":64,"phone":65,"phoneExt":16,"email":66},"CONTACT","(713) 566-4605","Asha.B.Bhalwal@uth.tmc.edu",{"name":68,"role":64,"phone":69,"phoneExt":16,"email":70},"Aya Sasson Mohr","(713) 500-6412","Aya.MohrSasson@uth.tmc.edu",[72],{"facility":5,"status":16,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Houston","Texas","77030","United States","US",{"type":79,"coordinates":80},"Point",[81,82],-95.36327,29.76328,{"lat":82,"lon":81},[85,86],{"name":60,"role":64,"phone":65,"phoneExt":16,"email":66},{"name":68,"role":64,"phone":69,"phoneExt":16,"email":70},{"type":61,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"Asha Bhalwal","Associate Professor Non-Tenure Clinical","100657577","phase-1-long-acting-local-vaginal-cuff-anesthesia-following-hysterectomy-100657577",false,"NCT07842159","Long-acting Local Vaginal Cuff Anesthesia Following Hysterectomy","Long-acting Local Vaginal Cuff Anesthesia Following Hysterectomy: LAVA Trial","LAVA","Inclusion Criteria:\n\n* at least 66.5kg weight\n* elective Robotic assisted (RA) Total Laparoscopic Hysterectomy (TLH) for benign indications at Memorial Hermann Hospital Texas Medical Center, Memorial Hermann Hospital Cypress and Memorial Hermann Hospital Greater Heights.\n\nExclusion Criteria:\n\n* Combined operation or alternative approach\n* inpatient overnight admission","FEMALE","18 Years",{"count":101,"type":102},104,"ESTIMATED","INTERVENTIONAL",[105,106],"PHASE1","PHASE2","The purpose of this study is to compare recovery unit and post operation day (POD) 1 pain score in women following elective robotic assisted TLH (RA-TLH) for benign indication with and without local vaginal cuff injection of short acting bupivacaine and long acting Exparel, to evaluate postoperative pain management and control by assessing the amount and frequency of NSAIDS and opioids taken and to assess bleeding, vaginal discharge and or vaginal dehiscence at the postoperative follow up visit.",[109],"Pain, Postoperative",[111,112,113],"elective Robotic assisted (RA) Total Laparoscopic Hysterectomy (TLH)","Total Laparoscopic Hysterectomy (TLH)","Benign","NOT_YET_RECRUITING","2026-09-20",{"date":117,"type":118},"2026-09-25","ACTUAL",{"date":120,"type":102},"2026-09-17",{"date":122,"type":102},"2028-09-15",{"name":5,"class":6},1]