[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100454106":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":83,"collaborators":86,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":26,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":26,"enrollmentInfo":98,"targetDuration":26,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"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",[47,70],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Vancouver Prostate Centre","RECRUITING","Vancouver","British Columbia","V5Z 1M9","Canada","CA",{"type":56,"coordinates":57},"Point",[58,59],-123.11934,49.24966,{"lat":59,"lon":58},[62,67],{"name":63,"role":39,"phone":64,"phoneExt":65,"email":66},"ST-CP-201 Study Clinical Trials Coordinator","604-875-4111","67898","clinic@ubcurology.com",{"name":68,"role":69,"phone":26,"phoneExt":26,"email":26},"Ryan Flannigan, MD","SUB_INVESTIGATOR",{"facility":71,"status":49,"city":50,"state":51,"zip":72,"country":53,"countryCode":54,"cosmosGeoPoint":73,"geoPoint":75,"contacts":76},"St. Pauls Hospital","V7Z1Y6",{"type":56,"coordinates":74},[58,59],{"lat":59,"lon":58},[77,80],{"name":63,"role":39,"phone":78,"phoneExt":26,"email":79},"604 806 8711","mobermayer@providencehealth.bc.ca",{"name":81,"role":82,"phone":26,"phoneExt":26,"email":26},"Amadeep Ghuman, MD","PRINCIPAL_INVESTIGATOR",{"type":82,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"David Harriman","Assistant Professor, Department of Urologic Sciences",[87],{"name":34,"class":88},"INDUSTRY","100454106","phase-2-sustained-release-lidocaine-for-the-treatment-of-postoperative-pain-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":99,"type":100},120,"ESTIMATED","INTERVENTIONAL",[103],"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.",[106,107],"Postoperative Pain","Postsurgical Pain",[109,110,111,112,113,114],"pelvic surgery","scrotal surgery","inguinal incision","circumcision","hemorrhoidectomy","fistulotomy","2025-02-04",{"date":117,"type":118},"2025-02-07","ACTUAL",{"date":120,"type":118},"2021-10-27",{"date":122,"type":100},"2026-05-27",{"name":5,"class":6},2]