[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609365":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":45,"responsibleParty":64,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":26,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":26,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":89,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Paracervical block","EXPERIMENTAL","Participants randomized to this experimental arm will receive a paracervical block with 0.5% bupivacaine with epinephrine at the time of vaginal hysterectomy with prolapse repair",[13],"Drug: Bupivacaine-epinephrine",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants randomized to this experimental arm will receive a placebo paracervical injection with normal saline at the time of vaginal hysterectomy with prolapse repair",[19],"Drug: Normal saline",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Bupivacaine-epinephrine","Participants randomized to this experimental arm will receive a paracervical block with 10 mL 0.5% bupivacaine with epinephrine before their vaginal hysterectomy and prolapse repair",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Normal saline","Participants randomized to this experimental arm will receive a placebo paracervical injection with 10 mL 0.5% normal saline before their vaginal hysterectomy and prolapse repair",[15],[15],[33],{"name":34,"affiliation":35,"role":36},"Bertie Geng, MD","University of North Carolina","PRINCIPAL_INVESTIGATOR",[38,42],{"name":34,"role":39,"phone":40,"phoneExt":26,"email":41},"CONTACT","984-974-0496","bertie.geng@unchealth.unc.edu",{"name":43,"role":39,"phone":26,"phoneExt":26,"email":44},"Marcella Willis-Gray, MD","Marcella_Willis-Gray@med.unc.edu",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX","RECRUITING","Raleigh","North Carolina","27607","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-78.63861,35.7721,{"lat":58,"lon":57},[61,62,63],{"name":34,"role":39,"phone":40,"phoneExt":26,"email":41},{"name":43,"role":39,"phone":26,"phoneExt":26,"email":44},{"name":34,"role":36,"phone":26,"phoneExt":26,"email":26},{"type":65,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100609365","phase-4-paracervical-injection-and-opioid-use-after-vaginal-hysterectomy-for-prolapse-100609365",false,"NCT07213635","Paracervical Injection and Opioid Use After Vaginal Hysterectomy for Prolapse","Effect of Paracervical Block on Postoperative Opioid Use in Vaginal Hysterectomy for Prolapse: a Randomized, Placebo-Controlled Trial","Inclusion Criteria:\n\n* Individuals undergoing vaginal hysterectomy with concomitant prolapse repair procedure\n\nExclusion Criteria:\n\n* Non-English speaking\n* Weight less than 50 kg\n* Allergy to bupivacaine\n* Pregnant",true,"FEMALE","18 Years",{"count":77,"type":78},56,"ESTIMATED","INTERVENTIONAL",[81],"PHASE4","The goal of the study to see if giving a numbing medicine around the cervix (called a paracervical block) during vaginal hysterectomy with prolapse repair helps people feel less pain and need fewer strong pain medicines afterward.\n\nThe main question it aims to answer is:\n\n• Does receiving a paracervical block at the time of vaginal hysterectomy with prolapse repair reduce postoperative opioid use?\n\nResearchers will compare opioid use in participants who receive the an injected numbing medicine (bupivacaine with lidocaine) to those that receive a saltwater liquid placebo.\n\nParticipants will:\n\n* Receive either an injection of the numbing medicine (bupivacaine with lidocaine) or saltwater liquid placebo after they are asleep but before any other parts of the surgery are done\n* Record and report pain medications used for 7 days after surgery\n* Report pain scores before discharge from the post anesthesia recovery area on day of surgery as well as 1 and 7 days after surgery\n* Complete a surgical recovery questionnaire during 6 week postoperative visit\n* Complete a one page multiple-choice test on pelvic organ prolapse",[84,85,86,87,88],"Opioid Use","Surgical Recovery","Vaginal Hysterectomy","Prolapse Pelvic","Postoperative Pain",[90,91,92,93,94,95],"paracervical block","vaginal hysterectomy","prolapse repair","postoperative opioid use","postoperative pain scores","postoperative recovery","2025-10-22",{"date":98,"type":99},"2025-10-24","ACTUAL",{"date":101,"type":99},"2025-10-20",{"date":103,"type":78},"2026-12",{"name":5,"class":6},1]