[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535502":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":44,"responsibleParty":63,"collaborators":34,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":34,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":34,"enrollmentInfo":77,"targetDuration":34,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":47,"whyStopped":34,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"United States Naval Medical Center, Portsmouth","FED",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Liposomal bupivacaine and bupivacaine plain erector spinae plane block","ACTIVE_COMPARATOR","Erector spinae plane block performed on the surgical side (left, right or bilateral) as appropriate based on planned surgical consent. Utilizing ultrasound to see the fascial layers and guide the needle placement under direct visualization. Block will include 1.33% liposomal bupivacaine 10ml plus 0.25% bupivacaine plain 20 ml per side of the block.",[13],"Drug: Liposomal bupivacaine",{"label":15,"type":16,"description":17,"interventionNames":18},"Bupivacaine plain with dexmedetomidine","EXPERIMENTAL","Erector spinae plane block performed on the surgical side (left, right or bilateral) as appropriate based on planned surgical consent. Utilizing ultrasound to see the fascial layers and guide the needle placement under direct visualization. Block will include 0.25% bupivacaine plain 30 ml plus dexmedetomidine 0.5 mcg\u002Fkg per side of the block.",[19],"Drug: Dexmedetomidine",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Dexmedetomidine","block duration extension additive",[15],[27],"Precedex",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Liposomal bupivacaine","Control arm, comparison for block duration with dexmedetomidine",[9],[33],"Exparel",null,[36,41],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Grant A Miller, DO","CONTACT","757-953-3238","grant.a.miller7.mil@health.mil",{"name":42,"role":38,"phone":39,"phoneExt":34,"email":43},"Trevor O Elam, MD","trevor.o.elam.mil@health.mil",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Naval Medical Center Portsmouth","RECRUITING","Portsmouth","Virginia","23708","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-76.29827,36.83543,{"lat":57,"lon":56},[60],{"name":61,"role":38,"phone":62,"phoneExt":34,"email":40},"Grant A Miller, LCDR, DO, Anesthesiologist","2678722411",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Grant Miller","Chair Acute Pain Service Anesthesia Department, Principal Investigator, Clinical Professor","100535502","phase-4-liposomal-bupivacaine-vs-bupivacaine-with-dexmedetomidine-in-erector-spinae-plane-blocks-for-mastectomies-100535502",false,"NCT06252662","Liposomal Bupivacaine Vs Bupivacaine with Dexmedetomidine in Erector Spinae Plane Blocks for Mastectomies","Liposomal Bupivacaine Vs Bupivacaine with Dexmedetomidine in an Erector Spinae Plane Block for Mastectomies in Cancer Patients: a Randomized Control Trial","Inclusion Criteria:\n\n* Patients requiring any variation of mastectomy with or without axillary lymph node dissection.\n* Patient agrees to a peripheral nerve block.\n* Patient agrees to be a study participant.\n* APS team believes a peripheral nerve block would be appropriate for the patient after reviewing medical\u002Fsurgical history.\n* Surgeon agrees with the block plan by APS.\n\nExclusion Criteria:\n\n* Patient declines a peripheral nerve block.\n* Patient declines to be a study participant.\n* APS team believes a peripheral nerve block is not clinically indicated.\n* Surgeon does not want a peripheral nerve block.\n* Patient has allergy to local anesthestic.\n* Patient has an active infection at the site of the peripheral nerve block.\n* Patient with pre-existing neural deficits along the distribution of the block.\n* Patient with coagulopathy.\n* Patient taking antithrombotic drugs outside the ASRA guidelines.\n* Patients weight is less that 50 kg due to concerns for local anesthetic toxicity syndrome.",true,"ALL","18 Years",{"count":78,"type":79},200,"ESTIMATED","INTERVENTIONAL",[82],"PHASE4","Perform a comparison of effective pain relief duration between liposomal bupivacaine and dexmedetomidine when added to bupivacaine in a block for mastectomy for cancer surgery. The erector spinae plane block is a well-established block that is utilized for post operative pain control for procedures performed on the soft tissue of the chest and chest wall as well as intrathoracic procedures. The goal is comparison of the effective duration of both study groups to determine if there is a significant difference in time and amount of post operative opioids required which admitted to hospital.",[85],"Breast Cancer",[87,88,89,90,91,92,93,33],"erector spinae plane block","bupivacaine","morphine equivalents","pain score","post-operative pain","post-surgical pain","liposomal bupivacaine","2024-11-15",{"date":96,"type":97},"2024-11-19","ACTUAL",{"date":99,"type":97},"2024-10-15",{"date":101,"type":79},"2025-10",{"name":5,"class":6},1]