[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100450537":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":37,"locations":48,"responsibleParty":64,"collaborators":42,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":42,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":42,"overallStatus":50,"whyStopped":42,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Gangnam Severance Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Opioid-free anesthesia group","ACTIVE_COMPARATOR","OFA group will be sedated using dexmedetomidine and lidocaine during mastectomy.",[13],"Procedure: Opioid-free anesthesia",{"label":15,"type":10,"description":16,"interventionNames":17},"Conventional anesthesia group with opioid","Conventional opioid anesthesia group will be sedated using remi-fentanyl during mastectomy.",[18],"Procedure: Conventional opioid-based anesthesia",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Opioid-free anesthesia","OFA group will be sedated using dexmedetomidine and lidocaine.",[9],[26],"Dexmedetomidine and lidocaine-based anesthesia",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Conventional opioid-based anesthesia","Conventional opioid-based anesthesia group will be sedated using remi-fentanyl",[15],[32],"Remi-fentanyl",[34],{"name":35,"affiliation":5,"role":36},"Sung Gwe G Ahn, M.D.,Ph.D.","PRINCIPAL_INVESTIGATOR",[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Sung Gwe Ahn, M.D.,Ph.D.","CONTACT","82220194402",null,"asg2004@yuhs.ac",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Soong June Bae, M.D.","82220193370","mission815815@yuhs.ac",[49],{"facility":5,"status":50,"city":51,"state":42,"zip":52,"country":53,"countryCode":42,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Seoul","135270","South Korea",{"type":55,"coordinates":56},"Point",[57,58],126.9784,37.566,{"lat":58,"lon":57},[61],{"name":62,"role":40,"phone":63,"phoneExt":42,"email":43},"Sung Gwe Ahn, MD, PhD","82-2-2019-3370",{"type":36,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Sung Gwe Ahn","Assocaite Professor","100450537","a-study-to-reduce-persistent-post-mastectomy-pain-using-opioid-free-anesthesia-100450537",false,"NCT05146778","A Study to Reduce Persistent Post-mastectomy Pain Using Opioid-free Anesthesia","A Single-blinded Randomized-controlled Study to Reduce Persistent Post-mastectomy Pain Using Multimodal Opioid-free Anesthesia","RELIEF","Inclusion Criteria:\n\n* All of patients will undergo mastectomy with or without immediate breast reconstruction.\n\nExclusion Criteria:\n\n* Previous history of breast surgery\n* Allergy to drug\n* Other cancer history\n* Underlying psychologic disorder\n* Patients with chronic pain requiring pain killers\n* Baseline SpO2 \\\u003C95%\n* Left ventricular EF \\\u003C40%\n* Bradycardia as HR \\\u003C50 bpm\n* BMI \\>35kg\u002Fm2\n* Pregnant woman","FEMALE","19 Years","80 Years",{"count":79,"type":80},230,"ESTIMATED","INTERVENTIONAL",[83],"NA","In 230 patients undergoing mastectomy, the investigators will compare opioid-free anesthesia (OFA) versus conventional opioid-based anesthesia in terms of chronic pain. The enrolled patients will be randomly assigned into two groups with 1:1 ratio. Chronic pain will be evaluated at 1 year after mastectomy based on the Breast Cancer Pain Questionnaire (BCPQ). Baseline pain sensitivity test and psychologic evaluation will be done before operation.",[86,87,88,89],"Breast Cancer","Mastectomy","Pain, Chronic","Pain, Post Operative","2025-11-18",{"date":92,"type":93},"2025-11-21","ACTUAL",{"date":95,"type":93},"2021-12-16",{"date":97,"type":80},"2027-10-31",{"name":5,"class":6},1]