[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100296158":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":38,"centralContacts":42,"locations":26,"responsibleParty":51,"collaborators":26,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":26,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":26,"enrollmentInfo":62,"targetDuration":26,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":26,"overallStatus":71,"whyStopped":26,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":26},{"fullName":5,"class":6},"Western University, Canada","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"WALANT","EXPERIMENTAL","These patients will receive local anesthetic for flexor tendon repair injected directly into the operative site on the hand. The local anesthetic used 1% lidocaine with 1:100,000 epinephrine.",[13,14],"Procedure: WALANT","Drug: WALANT Injection",{"label":16,"type":17,"description":18,"interventionNames":19},"General\u002Fregional anesthesia","ACTIVE_COMPARATOR","These patients will receive general\u002Fregional anesthesia for flexor tendon repair. This is ropivacaine 0.5% injected by an anesthetist under image-guidance in the axillary region of the arm. If the regional anesthesia is not functioning at the time of OR, this is converted to a general anesthetic as per standard protocol.",[20,21],"Procedure: General\u002Fregional anesthesia","Drug: Regional Anesthetic Injection",[23,27,29,34],{"type":24,"name":9,"description":11,"armGroupLabels":25,"otherNames":26},"PROCEDURE",[9],null,{"type":24,"name":16,"description":18,"armGroupLabels":28,"otherNames":26},[16],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":26},"DRUG","WALANT Injection","1% lidocaine with 1:100,000 epinephrine injected directly into operative site. The typical quantity is 5-10cc aliquots.",[9],{"type":30,"name":35,"description":36,"armGroupLabels":37,"otherNames":26},"Regional Anesthetic Injection","0.5% ropivacaine injected under ultrasound guidance into the axilla. The typical quantity is 30-40cc aliquots.",[16],[39],{"name":40,"affiliation":5,"role":41},"Ruby Grewal, MD MSc FRCSC","PRINCIPAL_INVESTIGATOR",[43,47],{"name":40,"role":44,"phone":45,"phoneExt":26,"email":46},"CONTACT","519-646-6286","rgrew@uwo.ca",{"name":48,"role":44,"phone":49,"phoneExt":26,"email":50},"Tym Frank, MD, FRCSC","778-870-5772","tym.frank@gmail.com",{"type":52,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100296158","wide-awake-local-anesthesia-vs-regionalgeneral-anesthesia-for-flexor-tendon-repair-100296158",false,"NCT03135340","Wide-Awake Local Anesthesia vs. Regional\u002FGeneral Anesthesia for Flexor Tendon Repair","Comparison of Wide-Awake Local Anesthesia vs. Regional\u002FGeneral Anesthesia for Hand Flexor Tendon Repair in Zones I and II: a Prospective Randomized Controlled Trial","Inclusion Criteria:\n\n* over the age of 18\n* acute single or multiple digit complete flexor tendon lacerations in zones I or II presenting to attending physicians who agree to participate in the study.\n\nExclusion Criteria:\n\n* gross wound contamination\n* segmental tendon loss\n* associated finger fractures\n* sub-acute or chronic ruptures (ruptures \\> 6 weeks old)\n* active or previous infection in the wound bed\n* requirement of delayed repair\n* complex or multisystem injuries\n* multiple digit injuries\n* significant joint injuries\n* amputations (replants)\n* mangled hand injuries.","ALL","18 Years",{"count":63,"type":64},88,"ESTIMATED","INTERVENTIONAL",[67],"NA","Wide-awake hand surgery with local anesthetic, no tourniquet and no sedation (WALANT) is increasingly utilized. Conventional anesthesia for hand surgery involves a patient with a block, unable to perform motor function in the arm, and with patient either intubated or sedated, unable to follow surgeon instructions intra-operatively. Flexor tendon repair with a wide awake and cooperative patient is routinely performed successfully at some centres. This method provides several potential benefits including being able to have the patient actively flex the digit and visualize the repair site to assess for any tendon gapping at the repair site, ensure adequate approximation, gliding and absence of triggering. There have not been any prospectively collected randomized controlled trials comparing wide awake vs. regional\u002Fgeneral anesthesia in flexor tendon repair. The purpose of our study is to assess for differences in early outcomes including stiffness, patient satisfaction and early complications in wide-awake anesthesia when compared to general\u002Fregional anesthesia for flexor tendon repair in zones I and II. Our hypothesis is that there is a lower complication rate and better outcomes when using wide-awake flexor tendon repair.",[70],"Tendon Injury - Hand","NOT_YET_RECRUITING","2017-07-12",{"date":74,"type":75},"2017-07-17","ACTUAL",{"date":77,"type":64},"2017-08",{"date":79,"type":64},"2033-11",{"name":81,"class":6},"University of Western Ontario, Canada"]