[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625929":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":39,"slug":26,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":40,"sex":46,"minAge":47,"maxAge":26,"enrollmentInfo":48,"targetDuration":26,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":66,"whyStopped":26,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":26},{"fullName":5,"class":6},"Hadassah Medical Organization","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Bupivacaine surgical site injection","ACTIVE_COMPARATOR","Participants undergoing TVT or TVT-O surgery for stress urinary incontinence will receive a 5 mL injection of 0.5% bupivacaine into the trans-obturator\u002Flevator ani muscle sling insertion site at the end of the procedure. All participants will receive standard postoperative care, including systemic analgesics as needed.",[13],"Drug: Bupivacain (Postoperative)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo: Saline Injection","PLACEBO_COMPARATOR","Participants undergoing TVT or TVT-O surgery for stress urinary incontinence will receive a 5 mL injection of normal saline into the same surgical site at the end of the procedure. All participants will receive standard postoperative care, including systemic analgesics as needed.",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Bupivacain (Postoperative)","A 5 mL injection of 0.5% bupivacaine will be administered into the trans-obturator\u002Flevator ani sling insertion site at the end of the TVT or TVT-O procedure, prior to wound closure.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Participants will receive a 5 mL injection of sterile 0.9% normal saline into the trans-obturator\u002Flevator ani sling insertion site at the end of the TVT or TVT-O procedure, prior to wound closure.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Nir Cohen, MD-MPh","CONTACT","00972506716211","nirco@hadassah.org.il",{"type":38,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100625929",false,"NCT07429019","Intraoperative Bupivacaine Injection to Reduce Acute and Chronic Pain After TVT\u002FTVT-O Surgery. Randomized Double-Blind Trial","Reduction of Post-surgery Pelvic Pain by Bupivacaine Injection During TVT\u002F TVT-O Procedure","PAIN-TVT","Inclusion Criteria:\n\n* Women aged 18 years or older\n* Scheduled to undergo vaginal surgery including TVT or TVT-O procedure for stress urinary incontinence\n* Able and willing to provide written informed consent\n* Willing to complete postoperative follow-up assessments for at least 6 months\n\nExclusion Criteria:\n\n* Planned concomitant abdominal, laparoscopic, or robotic surgery\n* Pre-existing chronic pelvic pain\n* Diagnosis of fibromyalgia\n* Diagnosis of endometriosis\n* Inability to complete follow-up assessments\n* Inability to provide informed consent","FEMALE","18 Years",{"count":49,"type":50},60,"ESTIMATED","INTERVENTIONAL",[53],"NA","This randomized, double-blind controlled trial will evaluate whether intraoperative injection of bupivacaine at the sling insertion site reduces postoperative pelvic and thigh pain in women undergoing TVT or TVT-O surgery for stress urinary incontinence. Women aged 18 years and older scheduled for vaginal surgery including a mid-urethral sling procedure will be randomly assigned to receive either 0.5% bupivacaine or saline injection at the surgical site at the end of the procedure.\n\nPostoperative pain will be assessed using the Numerical Rating Scale (NRS) within 24 hours after surgery, at one month, and at least six months postoperatively. The study will also evaluate opioid consumption and examine the relationship between early postoperative pain and the development of chronic postsurgical pain. The results may help determine whether local anesthetic injection during sling surgery can improve short- and long-term pain outcomes.",[56,57,58,59],"Pain After Surgery","PSP","Chronic Pain Syndrome","Local Anesthesia Infiltration",[61,62,63,64,65],"TVT","TVTO","Mid Urethral Sling","pain","chronic pain syndrom","NOT_YET_RECRUITING","2026-06-20",{"date":69,"type":70},"2026-06-23","ACTUAL",{"date":72,"type":50},"2026-07-01",{"date":74,"type":50},"2027-10-01",{"name":5,"class":6}]