[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558822":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":37,"locations":43,"responsibleParty":59,"collaborators":26,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":26,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Women's College Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Saddle block with intrathecal morphine Group","EXPERIMENTAL","Patients will receive a multimodal analgesic regimen with acetaminophen, NSAIDs and opioids plus a surgeon-administered pudendal nerve block by anatomical landmarks with 50mL of Normal Saline, 30mL of 0.25% Bupivacaine with epinephrine 1:200.000 and 20mL Lidocaine 1%. A volume of 20 mL of this mixture is used for the pudendal nerve block, and infiltration of the surgical incision and bilateral spermatic cord block is performed with an additional 20 mL of the same mixture of local anesthetic. 30ml of the solution is used to soak the vaginal plug made of gauze that is put inside the vaginal canal by the end of the procedure.\n\nPatients who are randomized to the saddle block with intrathecal morphine will receive an injection of 5mg of heavy Bupivacaine 0.75% plus 100mcg of morphine injected in the intrathecal space.",[13,14],"Procedure: Saddle block","Procedure: pudendal nerve block",{"label":16,"type":17,"description":18,"interventionNames":19},"Control Group","SHAM_COMPARATOR","As part of the analgesic plan, all patients will receive a multimodal analgesic regimen with acetaminophen, NSAIDs and opioids plus a surgeon-administered pudendal nerve block by anatomical landmarks with 50mL of Normal Saline, 30mL of 0.25% Bupivacaine with epinephrine 1:200.000 and 20mL Lidocaine 1%. A volume of 20 mL of this mixture is used for the pudendal nerve block, and infiltration of the surgical incision and bilateral spermatic cord block is performed with an additional 20 mL of the same mixture of local anesthetic. 30ml of the solution is used to soak the vaginal plug made of gauze that is put inside the vaginal canal by the end of the procedure.\n\nPatients in this group will receive a non-invasive sham saddle block in addition to the care standard.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Saddle block","The injected solution will be comprised of 5mg of heavy Bupivacaine 0.75% plus 100mcg of Morphine will be injected into the intrathecal space.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"pudendal nerve block","As part of the analgesic plan, all patients will receive a multimodal analgesic regimen with acetaminophen, NSAIDs and opioids plus a surgeon-administered pudendal nerve block by anatomical landmarks with a mixture of Local Anesthetic as follows: 50mL of Normal Saline, 30mL of 0.25% Bupivacaine with epinephrine 1:200.000 and 20mL Lidocaine 1%. A volume of 20 mL of this mixture is used for the pudendal nerve block, and infiltration of the surgical incision and bilateral spermatic cord block is performed with an additional 20 mL of the same mixture of local anesthetic. 30ml of the solution is used to soak the vaginal plug made of gauze that is put inside the vaginal canal by the end of the procedure.",[16,9],[32,35],{"name":33,"affiliation":5,"role":34},"Richard Brull, MD","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":5,"role":34},"Laura Giron-Arango, MD",[38],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},"Didem Bozak","CONTACT","416-323-6008","didem.bozak@wchospital.ca",[44],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Toronto","Ontario","M5S 1B2","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-79.39864,43.70643,{"lat":55,"lon":54},[58],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},{"type":60,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100558822","saddle-block-with-it-morphine-for-penile-inversion-vaginoplasty-100558822",false,"NCT06556121","Saddle Block With IT Morphine for Penile Inversion Vaginoplasty","The Addition of a Saddle Block With Intrathecal Morphine for Analgesia in Transgender Patients Undergoing Penile Inversion Vaginoplasty: A Randomized Double-blind Placebo-controlled Trial","Inclusion Criteria:\n\n* ASA I-III patients\n* Ages 18-70 years\n* Penile Inversion Vaginoplasty\n\nExclusion Criteria:\n\n* Local infection\n* History of use of over 30mg oxycodone or equivalent per day.\n* Contraindication to a component of multi-modal analgesia\n* Complications or adverse events unrelated to the local anesthetic that precludes evaluation of the primary and secondary outcome measures.\n* Unable to speak or read English.\n* Revision and Vulvaplasty surgeries","MALE","18 Years","70 Years",{"count":72,"type":73},40,"ESTIMATED","INTERVENTIONAL",[76],"NA","Penile Inversion Vaginoplasty (PIV) is a transition-related surgery (TRS) that is associated with severe postoperative pain. The optimal pain management strategies for this surgery remain unknown. We hypothesized that the addition of a saddle block with intrathecal morphine would yield clinically important analgesic benefits.",[79],"Pain, Postoperative",[23,81,28,82,83],"transition","gender confirmation surgery","penile inversion Vaginoplasty","2025-08-07",{"date":86,"type":87},"2025-08-13","ACTUAL",{"date":84,"type":87},{"date":90,"type":73},"2026-12",{"name":5,"class":6},1]