[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100454106":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":82,"collaborators":85,"id":88,"slug":26,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":26,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":26,"enrollmentInfo":96,"targetDuration":26,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"University of British Columbia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (ST-01)","EXPERIMENTAL","Administration of ST-01 as single-dose into the cutaneous, subcutaneous and fascia region of the surgical site and\u002For as nerve block.",[13],"Drug: ST-01",{"label":15,"type":16,"description":17,"interventionNames":18},"Control (Standard of Care)","ACTIVE_COMPARATOR","Administration of Control (Lidocaine Hydrochloride Injection USP Xylocaine® or Bupivacaine Hydrochloride Injection USP Marcaine®) as single-dose into the cutaneous, subcutaneous and fascia region of the surgical site and\u002For as nerve block.",[19],"Drug: Control (Lidocaine Hydrochloride Injection USP Xylocaine® or Bupivacaine Hydrochloride Injection USP Marcaine®)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","ST-01","Administration of up to 8 mL ST-01 (70 mg\u002FmL lidocaine)",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Control (Lidocaine Hydrochloride Injection USP Xylocaine® or Bupivacaine Hydrochloride Injection USP Marcaine®)","Administration of up to 3 mg\u002Fkg bupivacaine hydrochloride injection (0.25%) or up to 4.5mg\u002Fkg lidocaine hydrochloride injection (0.5-1%)",[15],[32],{"name":33,"affiliation":34,"role":35},"Graeme Boniface, PhD","Sustained Therapeutics Inc.","STUDY_DIRECTOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Lesley Parker","CONTACT","604 875 5594","lparker@sustainedtx.com",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Graeme Boniface","604-875-5594","gboniface@prostatecentre.com",[47,69],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Vancouver Prostate Centre","RECRUITING","Vancouver","British Columbia","V5Z 1M9","Canada",{"type":55,"coordinates":56},"Point",[57,58],-123.11934,49.24966,{"lat":58,"lon":57},[61,66],{"name":62,"role":39,"phone":63,"phoneExt":64,"email":65},"ST-CP-201 Study Clinical Trials Coordinator","604-875-4111","67898","clinic@ubcurology.com",{"name":67,"role":68,"phone":26,"phoneExt":26,"email":26},"Ryan Flannigan, MD","SUB_INVESTIGATOR",{"facility":70,"status":49,"city":50,"state":51,"zip":71,"country":53,"cosmosGeoPoint":72,"geoPoint":74,"contacts":75},"St. Pauls Hospital","V7Z1Y6",{"type":55,"coordinates":73},[57,58],{"lat":58,"lon":57},[76,79],{"name":62,"role":39,"phone":77,"phoneExt":26,"email":78},"604 806 8711","mobermayer@providencehealth.bc.ca",{"name":80,"role":81,"phone":26,"phoneExt":26,"email":26},"Amadeep Ghuman, MD","PRINCIPAL_INVESTIGATOR",{"type":81,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"David Harriman","Assistant Professor, Department of Urologic Sciences",[86],{"name":34,"class":87},"INDUSTRY","100454106",false,"NCT05193227","Sustained Release Lidocaine for the Treatment of Postoperative Pain","A Randomized Phase 2 Trial of ST-01 (Sustained-release Lidocaine Polymer Solution for Injection) in Subjects Undergoing Pelvic Surgery","Inclusion Criteria:\n\n* Any sex, aged ≥ 19 years\n* Indication to undergo an operation with a planned pelvic incision\n* Able and willing to provide informed consent\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* If sexually active, is willing to use adequate birth control methods to prevent pregnancy over the course of the study\n\nExclusion Criteria:\n\n* History of chronic pain conditions associated with the use of opioids or steroids\n* Known allergic reactions to any components of the investigational product\n* Active infection involving the surgical site\n* Any contraindication to local anesthesia with lidocaine (e.g., known hypersensitivity to anesthetics of the amide type, known hypokalemia, complete heart block, anticoagulants (ASA permitted) antiarrhythmic medication)\n* Use of prohibited medications (quinidine, procainamide, disopyramide, lidocaine, mexiletine, flecainide, propafenone, amiodarone, dronedarone, ibutilide, dofetilide, sotalol, vernakalant)\n* Has participated in another clinical trial within 3 months prior to the Screening Visit or is planning to participate in another clinical trial during this trial period\n* Has any other surgical or medical condition that, in the judgment of the clinical Investigator might warrant exclusion or be contraindicated for safety reason","ALL","19 Years",{"count":97,"type":98},120,"ESTIMATED","INTERVENTIONAL",[101],"PHASE2","In this study, the investigators are testing a new formulation of lidocaine for its suitability in managing postoperative pain after pelvic (circumcision, inguinal, scrotal), perineal (hemorrhoidectomy) or perianal (fistulotomy) incisions. The new formulation ST-01 is a sustained release lidocaine formulation and is expected to provide pain relief over multiple days. Currently, the drug lidocaine is not available as an injectable slow-release formulation.",[104,105],"Postoperative Pain","Postsurgical Pain",[107,108,109,110,111,112],"pelvic surgery","scrotal surgery","inguinal incision","circumcision","hemorrhoidectomy","fistulotomy","2025-02-04",{"date":115,"type":116},"2025-02-07","ACTUAL",{"date":118,"type":116},"2021-10-27",{"date":120,"type":98},"2026-05-27",{"name":5,"class":6},2]