[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100444813":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":49,"responsibleParty":457,"collaborators":460,"id":462,"slug":463,"hasResults":464,"nctId":465,"briefTitle":466,"officialTitle":466,"acronym":467,"eligibilityCriteria":468,"healthyVolunteers":464,"sex":469,"minAge":470,"maxAge":43,"enrollmentInfo":471,"targetDuration":43,"studyType":474,"phases":475,"briefSummary":477,"conditions":478,"keywords":483,"overallStatus":52,"whyStopped":43,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":496},{"fullName":5,"class":6},"Monash University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lidocaine","ACTIVE_COMPARATOR","2% Lidocaine infusion intra-operative and 10% Lidocaine infusion post-operative.",[13],"Drug: lidocaine 2% and 10%",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","0.9% Saline infusion intra-operative and 0.9% Saline infusion post-operative.",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","lidocaine 2% and 10%","Lidocaine infusion:\n\n1. Commencing with an intravenous bolus after induction of anaesthesia, 0.125 ml\u002Fkg of lean body weight (LBW) of 2% lidocaine (2.5 mg\u002Fkg).\\*\n2. Followed by a 2% lidocaine intravenous infusion for the duration of surgery, 0.1665 ml\u002Fkg\u002Fh of LBW (3.33 mg\u002Fkg\u002Fhr).\\*\n3. A post-operative subcutaneous 0.0222 ml\u002Fkg\u002Fhr of LBW 10% lidocaine infusion for up to 24 hours thereafter (2.22 mg\u002Fkg\u002Fhr). Dosage will be capped at a maximum lean body weight of 68kg.\n\n   * \\*Day-case surgery receives intraoperative bolus and intraoperative infusion only",[9],[27],"Xylocaine (lidocaine) 2% and Xylocard (lidocaine) 10%",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"Placebo infusion:\n\n1. Commencing with an intravenous bolus after induction of anaesthesia, 0.125 ml\u002Fkg of lean body weight (LBW) of 0.9% Saline solution.\\*\n2. Followed by a 0.9% Saline solution intravenous infusion for the duration of surgery, 0.1665 ml\u002Fkg\u002Fh of LBW (3.33 mg\u002Fkg\u002Fhr).\\*\n3. A post-operative subcutaneous 0.0222 ml\u002Fkg\u002Fhr of LBW 0.9% Saline solution infusion for up to 24 hours thereafter (2.22 mg\u002Fkg\u002Fhr). Dosage will be capped at a maximum lean body weight of 68kg.\n\n   * \\*Day-case surgery receives intraoperative bolus and intraoperative infusion only",[15],[32],"0.9% Saline solution",[34],{"name":35,"affiliation":36,"role":37},"Tomas Corcoran","Royal Perth Hospital","PRINCIPAL_INVESTIGATOR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Gillian Ormond","CONTACT","+610399030387",null,"gillian.ormond@monash.edu",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},"Natalie Hird","+61 (0) 459 407 231","natalie.hird@health.wa.gov.au",[50,64,73,82,88,94,104,113,122,132,141,150,160,170,180,185,194,203,209,215,222,229,238,247,256,265,271,282,290,298,309,316,326,337,346,355,364,373,381,390,395,403,412,421,430,438,447],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":43},"Nepean Hospital","RECRUITING","Kingswood","New South 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Region","3204",{"type":59,"coordinates":322},[323,324],175.28333,-37.78333,{"lat":324,"lon":323},{"facility":327,"status":52,"city":328,"state":329,"zip":43,"country":330,"countryCode":331,"cosmosGeoPoint":332,"geoPoint":336,"contacts":43},"University Hospital Wishaw","Wishaw","Scotland","United Kingdom","UK",{"type":59,"coordinates":333},[334,335],-3.91667,55.76667,{"lat":335,"lon":334},{"facility":338,"status":52,"city":339,"state":43,"zip":340,"country":330,"countryCode":331,"cosmosGeoPoint":341,"geoPoint":345,"contacts":43},"Belfast City Hospital","Belfast","BT9 7AB",{"type":59,"coordinates":342},[343,344],-5.92541,54.59682,{"lat":344,"lon":343},{"facility":347,"status":52,"city":348,"state":43,"zip":349,"country":330,"countryCode":331,"cosmosGeoPoint":350,"geoPoint":354,"contacts":43},"Southmead Hospital, North Bristol Trust","Bristol","BS10 5NB",{"type":59,"coordinates":351},[352,353],-2.59665,51.45523,{"lat":353,"lon":352},{"facility":356,"status":224,"city":357,"state":43,"zip":358,"country":330,"countryCode":331,"cosmosGeoPoint":359,"geoPoint":363,"contacts":43},"Darlington Memorial Hospital","Darlington","DL3 6HX",{"type":59,"coordinates":360},[361,362],-1.55039,54.52429,{"lat":362,"lon":361},{"facility":365,"status":52,"city":366,"state":43,"zip":367,"country":330,"countryCode":331,"cosmosGeoPoint":368,"geoPoint":372,"contacts":43},"Russells Hall Hospital","Dudley","DY1 2HQ",{"type":59,"coordinates":369},[370,371],-2.08333,52.5,{"lat":371,"lon":370},{"facility":374,"status":52,"city":375,"state":43,"zip":43,"country":330,"countryCode":331,"cosmosGeoPoint":376,"geoPoint":380,"contacts":43},"Royal Liverpool and Broadgreen 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Tyne",{"type":59,"coordinates":399},[400,401],-1.61396,54.97328,{"lat":401,"lon":400},{"facility":404,"status":52,"city":405,"state":43,"zip":406,"country":330,"countryCode":331,"cosmosGeoPoint":407,"geoPoint":411,"contacts":43},"Norfolk and Norwich University Hospital","Norwich","NR4 7UY",{"type":59,"coordinates":408},[409,410],1.29834,52.62783,{"lat":410,"lon":409},{"facility":413,"status":52,"city":414,"state":43,"zip":415,"country":330,"countryCode":331,"cosmosGeoPoint":416,"geoPoint":420,"contacts":43},"Rotherham NHS Foundation Trust","Rotherham","S60 2UD",{"type":59,"coordinates":417},[418,419],-1.35678,53.43012,{"lat":419,"lon":418},{"facility":422,"status":52,"city":423,"state":43,"zip":424,"country":330,"countryCode":331,"cosmosGeoPoint":425,"geoPoint":429,"contacts":43},"Royal Hallamshire Hospital","Sheffield","S10 2JF",{"type":59,"coordinates":426},[427,428],-1.4659,53.38297,{"lat":428,"lon":427},{"facility":431,"status":52,"city":432,"state":43,"zip":43,"country":330,"countryCode":331,"cosmosGeoPoint":433,"geoPoint":437,"contacts":43},"University Hospital Southampton","Southampton",{"type":59,"coordinates":434},[435,436],-1.40428,50.90395,{"lat":436,"lon":435},{"facility":439,"status":52,"city":440,"state":43,"zip":441,"country":330,"countryCode":331,"cosmosGeoPoint":442,"geoPoint":446,"contacts":43},"St Helen's Hospital","St Helens","WA9 3DA",{"type":59,"coordinates":443},[444,445],-2.73333,53.45,{"lat":445,"lon":444},{"facility":448,"status":449,"city":450,"state":43,"zip":451,"country":330,"countryCode":331,"cosmosGeoPoint":452,"geoPoint":456,"contacts":43},"Torbay Hospital","ACTIVE_NOT_RECRUITING","Torquay","TQ2 7AA",{"type":59,"coordinates":453},[454,455],-3.52522,50.46198,{"lat":455,"lon":454},{"type":37,"investigatorFullName":458,"investigatorTitle":459,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Prof Tomas Corcoran","Chief Principal Investigator",[461],{"name":36,"class":6},"100444813","phase-3-long-term-outcomes-of-lidocaine-infusions-for-post-operative-pain-lolipop-trial-100444813",false,"NCT05072314","Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial","LOLIPOP","Inclusion Criteria:\n\n* Consenting adult female patients (≥18 years) undergoing mastectomy (unilateral or bilateral) or breast conserving surgery (unilateral or bilateral) for the primary excision of confirmed or suspected primary breast cancer under general anaesthesia (including those with simultaneous insertion of tissue expanders or implants)\\*. \\* this specifically excludes patients undergoing surgery for locoregional recurrence\n* American Society of Anaesthesiologist (ASA) physical scale 1-3\n\nExclusion Criteria:\n\n* Mastectomy or breast conserving surgery with add on procedures e.g laparoscopic salpingectomy\n* Where surgery is being performed for locoregional recurrence of breast cancer\n* Pre-existing pain at site of surgery, axilla, ipsilateral side of chest wall or the ipsilateral upper arm (at diagnosis prior to any tumor locating procedures)\n* Re-excision procedures where the margins at the index surgery have been deemed insufficient\n* When immediate autologous reconstruction surgery is planned\n* Where delayed autologous reconstruction surgery on the operative breast within one year is planned\n* Planned use of regional analgesia infusions\n* Impaired cognition\n* Pregnant or lactating females\n* Transgender patients\n* Known metastatic disease\n* History of anaphylaxis, sensitivity or known contraindication to lidocaine (or other amide local anaesthetic agents e.g. other amide local anaesthetic agents: ropivacaine, bupivacaine, mepivacaine, prilocaine, etidocaine), including patients with porphyria or methaemoglobinaemia\n* History of epilepsy\n* Baseline heart rate \\< 50 bpm or systolic blood pressure \\< 100mmHg.\n* Acute coronary event in the last three months\n* Cardiac conduction abnormalities, including; Atrial fibrillation, Heart block (all degrees), Bundle Branch Block or Fascicular block, Prolonged QT interval, Wolf Parkinson White syndrome, channelopathy such as Brugada syndrome. A preoperative Electrocardiogram (ECG) is not mandatory, unless clinically indicated\n* Abnormal serum potassium concentration (based upon site laboratory reference ranges)\n* Active liver disease e.g. viral hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease, haemochromatosis, other rarer causes)\n* Medications within the last 7 days which are known \u002F suspected to slow lidocaine metabolism (amiodarone, beta blockers, cimetidine, fluoroquinolones, fluvoxamine, imidazoles, macrolides, verapamil, HIV drugs)\n* Cardiac Failure (any documented heart failure at peroperative assessment or GP records)\n* Severe Renal Failure (Creatinine Clearance of less than 30ml\u002Fmin or dialysis dependent)\n* Co-administration of lidocaine within 24 hours prior to surgery for other reasons (e.g. lidocaine patches","FEMALE","18 Years",{"count":472,"type":473},4300,"ESTIMATED","INTERVENTIONAL",[476],"PHASE3","The LOLIPOP Trial is a large (n=4,300 patients) pragmatic, international, multicentre, prospective, randomised, double blind, placebo-controlled, parallel assessment, safety and effectiveness superiority study.",[479,480,481,482],"Breast Cancer","Breast Cancer Female","Breast Conserving Surgery","Mastectomy",[484,485,486],"Anaesthesia","Local Anaesthesia","Chronic Post Surgical Pain","2026-03-22",{"date":489,"type":490},"2026-03-25","ACTUAL",{"date":492,"type":490},"2022-07-27",{"date":494,"type":473},"2028-07",{"name":5,"class":6},47]