[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626818":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":46,"responsibleParty":62,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":26,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Bakirkoy Dr. Sadi Konuk Research and Training Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Paracervical Block (Bupivacaine)","EXPERIMENTAL","Participants will receive 10 mL of 0.5% bupivacaine administered as a paraservical injection during vNOTES uterosacral ligament suspension.",[13],"Drug: Bupivacaine",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo (Normal Saline)","PLACEBO_COMPARATOR","Participants will receive 10 mL of 0.9% normal saline administered as a paraservical injection during vNOTES uterosacral ligament suspension.",[19],"Drug: Normal Saline",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Bupivacaine","A total of 10 mL of 0.5% bupivacaine will be administered as a paraservical injection during vNOTES uterosacral ligament suspension. The solution will be prepared in identical syringes by independent personnel to maintain blinding.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Normal Saline","A total of 10 mL of 0.9% normal saline will be administered as a paraservical injection during vNOTES uterosacral ligament suspension. The solution will be prepared in identical syringes to ensure blinding.",[15],[32],"0.9% Sodium Chloride",[34],{"name":35,"affiliation":5,"role":36},"Erkan Göl, MD","PRINCIPAL_INVESTIGATOR",[38,42],{"name":35,"role":39,"phone":40,"phoneExt":26,"email":41},"CONTACT","+905398517917","drerkangol@gmail.com",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Keziban Doğan, Professor","+905356336207","drkzbn70@gmail.com",[47],{"facility":48,"status":49,"city":50,"state":50,"zip":51,"country":52,"countryCode":26,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Bakirkoy Dr. Sadi Konuk Training and Research Hospital","RECRUITING","Istanbul","34147","Turkey (Türkiye)",{"type":54,"coordinates":55},"Point",[56,57],28.94966,41.01384,{"lat":57,"lon":56},[60,61],{"name":35,"role":39,"phone":40,"phoneExt":26,"email":41},{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Erkan Gol","Principal Investigator","100626818","effect-of-paracervical-block-on-postoperative-pain-after-vnotes-uterosacral-ligament-suspension-100626818",false,"NCT07440576","Effect of Paracervical Block on Postoperative Pain After vNOTES Uterosacral Ligament Suspension","A Prospective Randomized Double-Blind Placebo-Controlled Trial Evaluating the Effect of Paracervical Block on Postoperative Pain After vNOTES Uterosacral Ligament Suspension","vNOTES-PB","Inclusion Criteria:\n\n* Female patients aged 18 years or older\n* Symptomatic pelvic organ prolapse requiring uterosacral ligament suspension (USLS)\n* Planned hysterectomy (vaginal hysterectomy or vNOTES hysterectomy) with concomitant BS or BSO, followed by vNOTES uterosacral ligament suspension\n* ASA physical status I-III\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to bupivacaine or local anesthetic agents\n* Chronic opioid use or chronic pain disorders\n* Previous pelvic radiation therapy\n* Severe hepatic or renal impairment\n* Coagulopathy or anticoagulant therapy contraindicating injection\n* Active pelvic infection\n* Pregnancy\n* Inability to understand the pain scoring system","FEMALE","18 Years",{"count":77,"type":78},58,"ESTIMATED","INTERVENTIONAL",[81],"NA","This study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of paracervical block on early postoperative pain after vaginal natural orifice transluminal endoscopic surgery (vNOTES) uterosacral ligament suspension.\n\nEligible patients undergoing vNOTES uterosacral ligament suspension for benign gynecologic indications will be randomly assigned in a 1:1 ratio to receive either 10 mL of 0.5% bupivacaine or 10 mL of normal saline as a paracervical injection during surgery.\n\nThe primary outcome is postoperative pain assessed using the Visual Analog Scale (VAS) at 6 hours after surgery. Secondary outcomes include pain scores at multiple time points within 24 hours, total analgesic consumption, length of hospital stay, and patient satisfaction.\n\nThe study aims to determine whether paracervical block provides clinically meaningful pain reduction in the early postoperative period following vNOTES procedures.",[84,85],"Pelvic Organ Prolapse (POP)","Postoperative Pain",[87,88,89,90,91,92],"vnotes","uterosacral ligament suspension","paracervical block","bupivacaine","minimally invasive surgery","enhanced recovery","2026-03-09",{"date":95,"type":96},"2026-03-11","ACTUAL",{"date":93,"type":96},{"date":99,"type":78},"2027-02",{"name":64,"class":6},1]