[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100437673":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":65,"centralContacts":69,"locations":75,"responsibleParty":94,"collaborators":34,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":34,"eligibilityCriteria":102,"healthyVolunteers":99,"sex":103,"minAge":104,"maxAge":34,"enrollmentInfo":105,"targetDuration":34,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":78,"whyStopped":34,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Cedars-Sinai Medical Center","OTHER",[8,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #1","ACTIVE_COMPARATOR","Depending on which one of the thirteen possible gender-affirming surgeries the participant is undergoing, a combination of the following anesthetic block(s) will be used in this arm at either the pre-incision, intra-op, mid-surgery, end of surgery, or continuous time points:\n\n* Bilateral spermatic cord block (0.5% bupivacaine, 10cc per spermatic cord)\n* Local anesthetic (0.25% or 0.5% bupivacaine + 1:200K epinephrine)\n* Bilateral ultrasound guided pudendal nerve block (20-40 cc of 0.25% bupivacaine + 1:200K epinephrine)\n* Ultrasound guided Continuous Infraclavicular Brachial Plexus Block\n* Ultrasound guided Continuous Femoral Nerve Block\n* Pecs I \\& II Block (0.25% bupivacaine: 15-30ml per side for Pecs I-III)",[13,14,15,16,17,18,19],"Other: Ultrasound guided Continuous Infraclavicular Brachial Plexus Block","Other: Ultrasound guided Continuous Femoral Nerve Block","Other: Ultrasound guided Pudendal Nerve Block","Drug: Bupivacaine","Other: Bilateral spermatic cord block","Other: Pecs I & II Block","Other: Local anesthetic",{"label":21,"type":10,"description":22,"interventionNames":23},"Surgery-specific general anesthetic + ultrasound guided peripheral nerve block #2","Depending on which one of the thirteen possible gender-affirming surgeries the participant is undergoing, a combination of the following anesthetic block(s) will be used in this arm at either the intra-op, post-op, or end of surgery time points:\n\n* Bilateral ultrasound-guided Transversus Abdominis Plane Block (40-60cc of 0.25% bupivacaine with 1:200K epinephrine)\n* Local anesthetic (0.25 or 0.5% bupivacaine + 1:200K epinephrine)",[16,24,19],"Other: Bilateral ultrasound guided Transversus Abdominis Plane Block",{"label":26,"type":10,"description":27,"interventionNames":28},"Surgery-specific general anesthetic + local anesthetic at incision site","Depending on which one of the thirteen possible gender-affirming surgeries the participant is undergoing, a combination of the following anesthetic block(s) will be used in this arm at either the mid-surgery or end of surgery time points:\n\n* Bilateral spermatic cord block (0.5% bupivacaine, 10cc per spermatic cord)\n* Local anesthetic (0.25 or 0.5% bupivacaine + 1:200K epinephrine)",[16,17,19],[30,35,38,42,49,53,57,61],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Ultrasound guided Continuous Infraclavicular Brachial Plexus Block","20cc of 0.25% bupivacaine + 1:200K epinephrine will be administered at start of case, 20cc of 0.25% bupivacaine + 1:200K epinephrine at end of case, and 6cc\u002Fhr of 0.25% bupivacaine at post-op \\[administered by anesthesiologist\\]",[9],null,{"type":6,"name":36,"description":32,"armGroupLabels":37,"otherNames":34},"Ultrasound guided Continuous Femoral Nerve Block",[9],{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":34},"Ultrasound guided Pudendal Nerve Block","20-40cc of 0.25% bupivacaine + 1:200K epinephrine \\[administered by anesthesiologist, pre-incision\\]",[9],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"DRUG","Bupivacaine","0.25% or 0.5% with or without 1:200K epinephrine",[26,9,21],[48],"Marcaine",{"type":6,"name":50,"description":51,"armGroupLabels":52,"otherNames":34},"Bilateral ultrasound guided Transversus Abdominis Plane Block","40-60cc of 0.25% bupivacaine + 1:200K epinephrine \\[administered by anesthesiologist post-op or at end of surgery\\]",[21],{"type":6,"name":54,"description":55,"armGroupLabels":56,"otherNames":34},"Bilateral spermatic cord block","10cc per spermatic cord of 0.5% bupivacaine \\[administered by surgeon @ intraop\\]",[26,9],{"type":6,"name":58,"description":59,"armGroupLabels":60,"otherNames":34},"Pecs I & II Block","0.25% bupivacaine: 15-30mL per side for Pecs I-III",[9],{"type":6,"name":62,"description":63,"armGroupLabels":64,"otherNames":34},"Local anesthetic","0.25% or 0.5% bupivacaine into the appropriate surgical site",[26,9,21],[66],{"name":67,"affiliation":5,"role":68},"Maurice M Garcia, M.D., MAS","PRINCIPAL_INVESTIGATOR",[70],{"name":71,"role":72,"phone":73,"phoneExt":34,"email":74},"Jenna Stelmar, BS","CONTACT","805-813-7882","jenna.stelmar@cshs.org",[76],{"facility":77,"status":78,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"Cedars-Sinai Medical Center - North and South Towers","RECRUITING","Los Angeles","California","90048","United States","US",{"type":85,"coordinates":86},"Point",[87,88],-118.24368,34.05223,{"lat":88,"lon":87},[91],{"name":67,"role":72,"phone":92,"phoneExt":34,"email":93},"310-423-4256","maurice.garcia@csmc.edu",{"type":68,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Maurice M. Garcia","Director of the Cedars-Sinai Transgender Surgery and Health Program","100437673","phase-3-development-of-effective-opioid-sparing-techniques-for-peri-operative-pain-management-of-transgender-patients-undergoing-gender-affirming-surgeries-100437673",false,"NCT04979338","Development of Effective, Opioid Sparing Techniques for Peri-operative Pain Management of Transgender Patients Undergoing Gender Affirming Surgeries","Inclusion Criteria:\n\n* Transgender persons 18 years and older\n* Undergoing gender affirming surgeries performed by either Dr. Maurice Garcia (orchiectomy only, vaginoplasty with or without canal \\& orchiectomy, colon-vaginoplasty, \\& peritoneal vaginoplasty; Stage I phalloplasty, or stage II phalloplasty); Dr. Edward Ray (feminizing chest surgery, masculinizing chest surgery, stage I phalloplasty); Dr. Amit Gupta (orchiectomy and peritoneal vaginoplasty only); or Dr. Yosef Nasseri (colon vaginoplasty surgery)\n\nExclusion Criteria:\n\n* Patients who do not meet the inclusion criteria above\n* Any contraindications to the study drugs.\n* Patients with neurologic deficits that preclude them from sensing pain.\n* Patients with implanted pain neuromodulator devices (e.g., neurostimulator)\n* Patients who do not speak English","ALL","18 Years",{"count":106,"type":107},640,"ESTIMATED","INTERVENTIONAL",[110],"PHASE3","This study will compare the current standard-of-care pain treatment regimen options that are available to patients who undergo gender-affirming surgery. The purpose of this research is to determine if any of these options are more (versus less) effective than the others to manage surgery related pain, after surgery.",[113],"Gender Dysphoria",[113,115,116,117,118,119,120,121,122,123,124],"Gender-Affirming Surgery","Peri-Operative Pain","Pain Management","Surgery Pain","Sex Reassignment Surgery","Gender Reassignment Surgery","Vaginoplasty","Phalloplasty","Quality Improvement","Opioid Use","2025-09-11",{"date":127,"type":128},"2025-09-17","ACTUAL",{"date":130,"type":128},"2021-11-11",{"date":132,"type":107},"2026-09-30",{"name":5,"class":6},1]