[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656116":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":25,"interventions":40,"overallOfficials":57,"centralContacts":61,"locations":67,"responsibleParty":82,"collaborators":13,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":13,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":13,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":13,"overallStatus":104,"whyStopped":13,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Mahidol University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Quality of recovery 15 (QoR15) score at 24 hours","Patient-reported QoR 15 at 24-hour and 48-hour postoperative","From enrollment to 48 hours postoperatively",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":20},"QUADRUPLE",[21,22,23,24],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[26,33],{"label":27,"type":28,"description":29,"interventionNames":30},"TPVB","ACTIVE_COMPARATOR","US guided TPVB",[31,32],"Procedure: TPVB","Drug: IV placebo infusion",{"label":34,"type":35,"description":36,"interventionNames":37},"IV LI","EXPERIMENTAL","IV Lidocaine infusion",[38,39],"Drug: IV Lidocaine infusion","Procedure: sham subcutaneous infiltration",[41,45,49,53],{"type":42,"name":27,"description":43,"armGroupLabels":44,"otherNames":13},"PROCEDURE","Single shot thoracic paravertebral block with 0.5% Ropivacaine plus adrenaline 5 mcg\u002Fml (total mixture 25 ml)",[27],{"type":46,"name":36,"description":47,"armGroupLabels":48,"otherNames":13},"DRUG","Patients receiving IV Lidocaine infusion of 1.5 mg\u002Fkg in 10 mins then continue 1.5mg\u002Fkg\u002Fh (= 0.075ml\u002Fkg in 10 mins then 0.075ml\u002Fkg\u002Fh) intraoperatively",[34],{"type":42,"name":50,"description":51,"armGroupLabels":52,"otherNames":13},"sham subcutaneous infiltration","2% Lidocaine 1-2 ml subcutaneously infiltrate to blind the patients and outcome assessor",[34],{"type":46,"name":54,"description":55,"armGroupLabels":56,"otherNames":13},"IV placebo infusion","infusion of normal saline at a same rate as IV LI (0.075ml\u002Fkg in 10 mins then 0.075ml\u002Fkg\u002Fh)",[27],[58],{"name":59,"affiliation":5,"role":60},"Chayapa Luckanachanthachote, MD","PRINCIPAL_INVESTIGATOR",[62],{"name":63,"role":64,"phone":65,"phoneExt":13,"email":66},"Chayapa Luckanachanthachote","CONTACT","+66 928266963","chayapa.anes@gmail.com",[68],{"facility":5,"status":13,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Bangkok Noi","Bangkok","10700","Thailand","TH",{"type":75,"coordinates":76},"Point",[77,78],100.47798,13.76266,{"lat":78,"lon":77},[81],{"name":5,"role":64,"phone":13,"phoneExt":13,"email":13},{"type":83,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100656116","quality-of-recovery-after-primary-breast-cancer-surgery-comparing-thoracic-paravertebral-block-and-intravenous-lidocaine-infusion-100656116",false,"NCT07823244","Quality of Recovery After Primary Breast Cancer Surgery Comparing Thoracic Paravertebral Block and Intravenous Lidocaine Infusion.","Quality of Recovery After Primary Breast Cancer Surgery: A Prospective, Multicentre, Randomized, Triple-Blinded Trial Comparing Thoracic Paravertebral Block and Intravenous Lidocaine Infusion.","Inclusion Criteria:\n\n* Adult ASA I-III patients between the age 18 to 75 years scheduled for primary breast cancer surgery-simple mastectomy and modified radical mastectomy with sentinel lymph node biopsy +\u002F- axillary dissection.\n\nExclusion Criteria:\n\n* Patient refusal, patients unable to comprehend QoR15 form, total body weight less than 40 Kg, local skin site infection, coagulopathy, history of allergy to local anaesthetics, and patients with hepatic, renal and cardiac dysfunction will be excluded.","ALL","18 Years","75 Years",{"count":95,"type":96},112,"ESTIMATED","INTERVENTIONAL",[99],"NA","The goal of this clinical trial is to learn whether an intravenous lidocaine infusion (IVLI) works as well as a thoracic paravertebral block (TPVB) - the current standard nerve-block technique - for improving recovery after breast cancer surgery. It will also learn about the safety of both approaches. The main questions it aims to answer are:\n\nDoes IVLI provide a similar quality of recovery (measured by the QoR-15 score at 24 hours) as TPVB? Does IVLI control pain during the first 24 hours after surgery (measured at rest and with arm movement) as well as TPVB?\n\nParticipants will:\n\nUndergo their planned breast cancer surgery (mastectomy or breast-conserving surgery with sentinel lymph node biopsy) under general anaesthesia, along with either the TPVB injection or the IVLI infusion, assigned at random Attend a preoperative visit the day before surgery to learn how to use the pain and self-quality-of-recovery questionnaire (QoR-15) Fill out a QoR-15 once a day for the first 48 hours after surgery Participants' pain score in hospital recorded during the first 48 hours after surgery, with rescue pain medication available if needed",[102,103],"Pain Management After Major Breast Surgery","Well Being After Major Breast Surgery","NOT_YET_RECRUITING","2026-09-11",{"date":107,"type":108},"2026-09-16","ACTUAL",{"date":110,"type":96},"2026-10-01",{"date":112,"type":96},"2029-09-30",{"name":5,"class":6},1]