[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100462363":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":44,"locations":54,"responsibleParty":96,"collaborators":98,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":103,"sex":109,"minAge":110,"maxAge":31,"enrollmentInfo":111,"targetDuration":31,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":57,"whyStopped":31,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: Standard of care","ACTIVE_COMPARATOR","1. Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL\n2. Routine, standard graft site hemostasis with monopolar cautery\n3. No suture closure of graft site\n4. No further infiltration of local anesthetic in mouth",[13],"Drug: Standard Buccal Harvest",{"label":15,"type":16,"description":17,"interventionNames":18},"Group 2: Standard of care + Long acting local","EXPERIMENTAL","1. Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL\n2. Routine, standard graft site hemostasis with monopolar cautery\n3. No suture closure of graft site\n4. Up to a maximum of 10mL of 0.5% bupivacaine infiltration in the buccal graft site",[19],"Drug: Basic buccal procedure + Long acting local",{"label":21,"type":16,"description":22,"interventionNames":23},"Group 3: Standard of care + Buccal block","1. Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL\n2. Routine, standard graft site hemostasis with monopolar cautery\n3. No suture closure of graft site\n4. Up to a maximum of 10mL of 0.5% bupivacaine infiltration as a buccal block",[24],"Drug: Basic buccal procedure + Buccal block",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Standard Buccal Harvest","Our institutions current anesthetic regimen. Comparison group",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Basic buccal procedure + Long acting local","Addition of long-acting local anesthetic to the wound bed following the oral graft harvest.",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Basic buccal procedure + Buccal block","Addition of long-acting local anesthetic as a buccal block after oral graft harvest",[21],[41],{"name":42,"affiliation":5,"role":43},"Lindsay Hampson, MD","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":31,"email":49},"Lindsay A Hampson, MD","CONTACT","415-353-2200","lindsay.hampson@ucsf.edu",{"name":51,"role":47,"phone":52,"phoneExt":31,"email":53},"Sara Z Amare, BS","(415) 514-7597","sara.amare@ucsf.edu",[55,77],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"University of California San Francisco","RECRUITING","San Francisco","California","94143","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-122.41942,37.77493,{"lat":67,"lon":66},[70,71,74,75],{"name":46,"role":47,"phone":48,"phoneExt":31,"email":49},{"name":72,"role":73,"phone":31,"phoneExt":31,"email":31},"Nathan M Shaw, MD","SUB_INVESTIGATOR",{"name":46,"role":43,"phone":31,"phoneExt":31,"email":31},{"name":76,"role":73,"phone":31,"phoneExt":31,"email":31},"Benjamin N Breyer, MD",{"facility":78,"status":57,"city":79,"state":80,"zip":81,"country":61,"countryCode":62,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"MedStar Urology","Washington D.C.","District of Columbia","20037",{"type":64,"coordinates":83},[84,85],-77.03637,38.89511,{"lat":85,"lon":84},[88,92],{"name":89,"role":47,"phone":90,"phoneExt":31,"email":91},"Nathan Shaw, MD","202-444-4922","nathan.m.shaw@medstar.net",{"name":93,"role":47,"phone":94,"phoneExt":31,"email":95},"Krishnan Venkatesan, MD","2024444922","krishnan.venkatesan@medstar.net",{"type":97,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[99],{"name":100,"class":6},"MedStar Georgetown University Hospital","100462363","phase-3-peri-operative-oral-pain-control-following-buccal-graft-urethroplasty-100462363",false,"NCT05300685","Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty","Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty: Randomized Control Trial of Harvest Site Anesthetic","Buccal","Inclusion Criteria:\n\n* Men, age 18 or older\n* Undergoing anterior urethroplasty with buccal grafting\n* Able to consent\n\nExclusion Criteria:\n\n* Taking chronic opiates for pain\n* Diagnosis of chronic pain\n* Prior buccal urethroplasty\n* Vulnerable population (e.g. prisoner)\n* Renal dysfunction or allergy preventing NSAID use\n* Liver dysfunction or allergy preventing Tylenol use\n* Medical allergy to local anesthetic\n* Medical allergy to Peridex\u002FMagic Mouthwash\n* NYHA Class III\u002FIV\n* Hematologic condition that excludes patient from surgery\n* Post-operative complication resulting in inpatient stay\n* Anesthetic complication\n* No buccal site surgical complication","MALE","18 Years",{"count":112,"type":113},60,"ESTIMATED","INTERVENTIONAL",[116],"PHASE3","Patients undergoing buccal urethroplasty will often have significant post-operative oral pain from the graft site. Various graft harvest techniques and methods for post-harvest hemostasis including graft site closure have been explored. Despite the frequency of this clinical scenario there is no established best practice for peri-operative pain management in this patient population. In addition to traditional post operative pain control, groups have sought various peri-operative anesthetic regimens to improve post operative pain. This has led recently to the description of various regional blocks including buccal and periorbital blocks for peri-operative local anesthetic. No study has looked at superiority of regional pain management in this patient population. This study will aim to assess three established anesthetic protocols for oral pain control in a blinded, randomized controlled trial.\n\nHypothesis: Patients who have buccal block will have lower post op pain without any increase adverse oral outcomes.",[119],"Urethral Stricture, Male",[121,122,123,124,125],"buccal urethroplasty","urethral stricture","urethroplasty","buccal block","lidocaine","2026-06-03",{"date":128,"type":129},"2026-06-05","ACTUAL",{"date":131,"type":129},"2022-02-15",{"date":133,"type":113},"2026-07-01",{"name":5,"class":6},2]