[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05575999":3,"trial-entities:NCT05575999":135,"trial-summary:NCT05575999":138},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":36,"secondary_outcomes":47,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":64,"eligibility_criteria":65,"std_ages":79,"locations":82,"central_contacts":104,"overall_officials":110,"references":114,"see_also_links":134},"NCT05575999","KCHRRF-PAINFREE POCKET-0016","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","NOT_YET_RECRUITING","2026-12","2024-10","2025-08-28","2026-01","Kansas City Heart Rhythm Research Foundation","OTHER",false,"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.","Bupivacaine is a widely used local anesthetic and is often administered by spinal injection prior to major surgical procedures. Ketorolac is a potent NSAID which is used for the short-term relief of moderate to severe pain. It's used for long term duration is generally limited due to its potential to cause GI ulcers\u002Fperforation and renal failure. A single dose of perioperative Ketorolac has been found to be effective in reducing opioid consumption. Ketamine is NMDA receptor antagonist and is used for its anesthetic, analgesic, and psychotomimetic effects. It is primarily used for induction and maintenance of anesthesia and induces a trance like state providing pain relief, sedation, and amnesia.\n\nAlthough an effective local anesthetic agent, bupivacaine has weak analgesic effect and is used in combination with several analgesic agents for effective perioperative and postoperative analgesia. A common drug used in this analgesic regimen usually includes opioids such as morphine, oxycodone, and fentanyl. Over the last few decades the United States has witnessed an opioid epidemic and post-surgical opioid prescription is one of the major contributors of this epidemic. An opioid free combination of Bupivacaine-Ketorolac-Ketamine (BKK) is thought to be effective in alleviating perioperative and postoperative pain.",[19],"Pain Management",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE1",{"count":26,"type":27},200,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"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.",[34,35],"Bupivacaine Alone","Bupivacaine-Ketorolac-Ketamine (BKK) Combination",[37,41,44],{"measure":38,"description":39,"timeFrame":40},"Comparative efficacy\u002Fsuperiority of BKK compared to bupivacaine alone in reducing the pain intensity","The goal of this prospective open label study is to demonstrate a comparative efficacy\u002Fsuperiority of BKK compared to bupivacaine alone in reducing the pain intensity. Patient's pain will be assessed using a Visual Analog Scale either through a telephone call from the research team or via clinic follow-up visit. The visual analog scale (VAS) determines pain from 0 to 10 with 0 indicating no pain (Better outcome) and 10 indicating worse pain in their life indicating (worse outcome).","Upto 1 week",{"measure":42,"description":43,"timeFrame":40},"Comparative efficacy\u002Fsuperiority of BKK compared to bupivacaine alone in providing comfort","The goal of this prospective open label study is to demonstrate a comparative efficacy\u002Fsuperiority of BKK compared to bupivacaine alone in providing comfort. Patient's comfort will be assessed using a verbal rating score either through a telephone call from the research team or via clinic follow-up visit. The comfort score determines patients comfort from 0 to 100 with 0 indicating extremely uncomfortable (Worse outcome) and 100 indicating extremely comfortable (Better outcome).",{"measure":45,"description":46,"timeFrame":40},"Comparative efficacy\u002Fsuperiority of BKK compared to bupivacaine alone in Quality of Life (QoL)","The goal of this prospective open label study is to demonstrate a comparative efficacy\u002Fsuperiority of BKK compared to bupivacaine alone in Quality of Life. Patient's Quality of Life will be assessed using a QoL score (EQ5-5D-5L) either through a telephone call from the research team or via clinic follow-up visit. The Quality of life questionnaire (EQ-5D-5L) has five response levels : no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5), with low values suggesting better outcomes and higher values suggesting worse outcomes.",[48,52,55,58],{"measure":49,"description":50,"timeFrame":51},"Hospital readmission rates","Hospital readmission rates due to device implantation related pain or surgical site infection will be analyzed.","Until 7 days (Until the end of the sutdy)",{"measure":53,"description":54,"timeFrame":51},"Adverse Effects","Rates of adverse effects, including allergic reaction, worsening of the renal function, presyncope\u002Fsyncope, HTN, drug-drug interaction or any patient reported side effects will be analyzed.",{"measure":56,"description":57,"timeFrame":40},"Cost comparison of medications","Cost of medications will be compared.",{"measure":59,"description":60,"timeFrame":40},"Amount of pain medication used","Amount of pain medication used will be analyzed","ALL","18 Years",null,true,{"inclusion":66,"exclusion":71,"raw_text":78},[67,68,69,70],"Both male and female patients","Patients older than 18 years of age","Patients undergoing new CIED (ICD, pacemaker, CRT-D or CRT-P)","Patients willing to participate in the study",[72,73,74,75,76,77],"Patients with prior history of allergic reaction to any component of the drug; bupivacaine, ketorolac, or ketamine","Pregnant or breastfeeding patients","Prisoners","Patients younger than 18 years of age","Patients not willing to participate in the study","Patients deemed not suitable or unstable for the study as per physician's discretion","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",[80,81],"ADULT","OLDER_ADULT",[83,92,100],{"facility":84,"city":85,"state":86,"zip":87,"country":88,"geoPoint":89},"Loma Linda University Health","Loma Linda","California","92350","United States",{"lat":90,"lon":91},34.04835,-117.26115,{"facility":93,"city":94,"state":95,"zip":96,"country":88,"geoPoint":97},"Kansas City Heart Rhythm Institute","Overland Park","Kansas","66211",{"lat":98,"lon":99},38.98223,-94.67079,{"facility":101,"city":94,"state":95,"zip":102,"country":88,"geoPoint":103},"Overland Park Regional Medical Center","66215",{"lat":98,"lon":99},[105],{"name":106,"role":107,"phone":108,"email":109},"Donita Atkins","CONTACT","816-651-1969","datkins@kchrf.com",[111],{"name":112,"affiliation":93,"role":113},"Dhanunjaya Lakkireddy, MD","PRINCIPAL_INVESTIGATOR",[115,119,122,125,128,131],{"pmid":116,"type":117,"citation":118},"34552003","BACKGROUND","Mariano ER, Dickerson DM, Szokol JW, Harned M, Mueller JT, Philip BK, Baratta JL, Gulur P, Robles J, Schroeder KM, Wyatt KEK, Schwalb JM, Schwenk ES, Wardhan R, Kim TS, Higdon KK, Krishnan DG, Shilling AM, Schwartz G, Wiechmann L, Doan LV, Elkassabany NM, Yang SC, Muse IO, Eloy JD, Mehta V, Shah S, Johnson RL, Englesbe MJ, Kallen A, Mukkamala SB, Walton A, Buvanendran A. A multisociety organizational consensus process to define guiding principles for acute perioperative pain management. Reg Anesth Pain Med. 2022 Feb;47(2):118-127. doi: 10.1136\u002Frapm-2021-103083. Epub 2021 Sep 22.",{"pmid":120,"type":117,"citation":121},"21965355","De Oliveira GS Jr, Agarwal D, Benzon HT. Perioperative single dose ketorolac to prevent postoperative pain: a meta-analysis of randomized trials. Anesth Analg. 2012 Feb;114(2):424-33. doi: 10.1213\u002FANE.0b013e3182334d68. Epub 2011 Sep 29.",{"pmid":123,"type":117,"citation":124},"30449428","Wolfe RC, Spillars A. Local Anesthetic Systemic Toxicity: Reviewing Updates From the American Society of Regional Anesthesia and Pain Medicine Practice Advisory. J Perianesth Nurs. 2018 Dec;33(6):1000-1005. doi: 10.1016\u002Fj.jopan.2018.09.005. No abstract available.",{"pmid":126,"type":117,"citation":127},"33367623","Nair GM, Birnie DH, Sumner GL, Krahn AD, Healey JS, Nery PB, Kalfon E, Verma A, Ayala-Paredes F, Coutu B, Becker G, Philippon F, Eikelboom J, Sandhu RK, Sapp J, Leather R, Yung D, Thibault B, Simpson CS, Ahmad K, Sturmer M, Kavanagh K, Crystal E, Wells GA, Essebag V; BRUISE CONTROL Investigators. Post-operative pain following cardiac implantable electronic device implantation: insights from the BRUISE CONTROL trials. Europace. 2021 May 21;23(5):748-756. doi: 10.1093\u002Feuropace\u002Feuaa349.",{"pmid":129,"type":117,"citation":130},"30983590","Neuman MD, Bateman BT, Wunsch H. Inappropriate opioid prescription after surgery. Lancet. 2019 Apr 13;393(10180):1547-1557. doi: 10.1016\u002FS0140-6736(19)30428-3.",{"pmid":132,"type":117,"citation":133},"15599137","Clerc S, Vuilleumier H, Frascarolo P, Spahn DR, Gardaz JP. Is the effect of inguinal field block with 0.5% bupivacaine on postoperative pain after hernia repair enhanced by addition of ketorolac or S(+) ketamine? Clin J Pain. 2005 Jan-Feb;21(1):101-5. doi: 10.1097\u002F00002508-200501000-00012.",[],{"nct_id":4,"conditions":136,"biomarkers":137},[19],[],{"nct_id":4,"found":64,"summary":139,"prompt_version":149},{"design":140,"status":141,"heading":142,"summary":143,"follow_up":144,"word_count":145,"commitments":146,"compensation":147,"drugs_mentioned":148},"This interventional study will compare two groups: one receiving Bupivacaine alone and another receiving a Bupivacaine-Ketorolac-Ketamine combination. It plans to enroll 200 participants.","completed","Pain Management for CIED Implants","This study is looking at ways to reduce pain after getting a cardiac implantable electronic device (CIED), like a pacemaker. Researchers are comparing a combination of three medications—Bupivacaine, Ketorolac, and Ketamine (BKK)—to Bupivacaine alone. Bupivacaine is a common numbing medicine. Ketorolac is for pain relief, and Ketamine can also help with pain and sedation. The goal is to see if the BKK combination is better at reducing pain, improving comfort, and enhancing your quality of life in the week after surgery. You may be able to join if you are over 18, having a new CIED implanted, and are willing to participate. You cannot join if you are allergic to any of the study drugs, are pregnant or breastfeeding, or are a prisoner. The study aims to enroll 200 participants, but its current status is unclear.","Participants will be followed for up to 1 week after treatment to assess pain, comfort, and quality of life.",136,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]