[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100483512":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":65,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":24,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":24,"enrollmentInfo":81,"targetDuration":24,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":24,"overallStatus":90,"whyStopped":24,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Kansas City Heart Rhythm Research Foundation","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Bupivacaine Alone","This is the control group of patients receiving 20 cc of 0.5% bupivacaine (Bupivacaine HCL 100 mg \\[5mg\u002Fml\\] alone. The dose and number of doses of the medicines will be adjusted as per discretion of the operator.",[12],"Drug: Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) Combination",{"label":14,"type":15,"description":16,"interventionNames":17},"Bupivacaine-Ketorolac-Ketamine (BKK) Combination","EXPERIMENTAL","This is the intervention group of patients receiving 20 cc combination of BKK (Bupivacaine HCl 60 mg \\[3 mg\u002FmL\\], Ketorolac Tromethamine 24 mg \\[1.2mg\u002FmL\\], Ketamine HCl 24 mg \\[1.2 mg\u002FmL\\]).The dose and number of doses of the medicines will be adjusted as per discretion of the operator.",[12],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) Combination","The plan will be to stratify patients in two groups: intervention group receiving 20 cc combination of BKK (Bupivacaine HCl 60 mg \\[3 mg\u002FmL\\], Ketorolac Tromethamine 24 mg \\[1.2mg\u002FmL\\], Ketamine HCl 24 mg \\[1.2 mg\u002FmL\\]) vs the control group receiving 20 cc of 0.5% bupivacaine (Bupivacaine HCL 100 mg \\[5mg\u002Fml\\]. The dose can be repeated multiple times during the procedure as per operator's discretion. The patients will be further stratified into sub-groups based on type of procedure they had undergone. Analgesia\u002Fanesthesia strategy will be local infiltration of the drug along with a sedating agent based on institutional standard of care. The dose of the medicines will be adjusted as per discretion of the operator to maintain adequate anesthesia\u002Fanalgesia during and after the procedure.",[9,14],null,[26],{"name":27,"affiliation":28,"role":29},"Dhanunjaya Lakkireddy, MD","Kansas City Heart Rhythm Institute","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":35},"Donita Atkins","CONTACT","816-651-1969","datkins@kchrf.com",[37,50,59],{"facility":38,"status":24,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":24},"Loma Linda University Health","Loma Linda","California","92350","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-117.26115,34.04835,{"lat":48,"lon":47},{"facility":28,"status":24,"city":51,"state":52,"zip":53,"country":42,"countryCode":43,"cosmosGeoPoint":54,"geoPoint":58,"contacts":24},"Overland Park","Kansas","66211",{"type":45,"coordinates":55},[56,57],-94.67079,38.98223,{"lat":57,"lon":56},{"facility":60,"status":24,"city":51,"state":52,"zip":61,"country":42,"countryCode":43,"cosmosGeoPoint":62,"geoPoint":64,"contacts":24},"Overland Park Regional Medical Center","66215",{"type":45,"coordinates":63},[56,57],{"lat":57,"lon":56},{"type":66,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[68],{"name":69,"class":70},"Cardiac Arrhythmia Service, Loma Linda University Health, Loma Linda, CA","UNKNOWN","100483512","phase-1-effectiveness-of-bupivacaine-ketorolac-ketamine-vs-bupivacaine-alone-in-reducing-postoperative-pocket-pain-100483512",false,"NCT05575999","Effectiveness of Bupivacaine, Ketorolac, Ketamine, vs Bupivacaine Alone in Reducing Postoperative Pocket Pain","Pain Management in Cardiac Implantable Electronic Device Insertion; Effectiveness of Bupivacaine, Ketorolac, Ketamine, vs Bupivacaine Alone in Reducing Postoperative Pocket Pain","Inclusion Criteria:\n\n* Both male and female patients\n* Patients older than 18 years of age\n* Patients undergoing new CIED (ICD, pacemaker, CRT-D or CRT-P)\n* Patients willing to participate in the study\n\nExclusion Criteria:\n\n* Patients with prior history of allergic reaction to any component of the drug; bupivacaine, ketorolac, or ketamine\n* Pregnant or breastfeeding patients\n* Prisoners\n* Patients younger than 18 years of age\n* Patients not willing to participate in the study\n* Patients deemed not suitable or unstable for the study as per physician's discretion",true,"ALL","18 Years",{"count":82,"type":83},200,"ESTIMATED","INTERVENTIONAL",[86],"PHASE1","Bupivacaine is the most widely used local anesthetic agent across majority of the Cardiac Implantable Electronic device (CIED) implant procedures in the United States. It is hypothesized that the combination of Bupivacaine-Ketorolac-Ketamine (BKK) is more effective in alleviating perioperative and postoperative pain as compared to the use of bupivacaine alone.\n\nA few studies have been done to look for the effectiveness of BKK in abdominal surgical procedures. However, no study has been done to evaluate its efficacy and effectiveness in patients undergoing CIED insertion.",[89],"Pain Management","NOT_YET_RECRUITING","2025-08-27",{"date":93,"type":94},"2025-08-28","ACTUAL",{"date":96,"type":83},"2026-01",{"date":98,"type":83},"2026-12",{"name":5,"class":6},3]