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.
A 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.
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
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
Parallel
Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) Combination
DrugThe plan will be to stratify patients in two groups: intervention group receiving 20 cc combination of BKK (Bupivacaine HCl 60 mg \[3 mg/mL\], Ketorolac Tromethamine 24 mg \[1.2mg/mL\], Ketamine HCl 24 mg \[1.2 mg/mL\]) vs the control group receiving 20 cc of 0.5% bupivacaine (Bupivacaine HCL 100 mg \[5mg/ml\]. 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/anesthesia 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/analgesia during and after the procedure.
Comparative efficacy/superiority 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/superiority 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).
Comparative efficacy/superiority of BKK compared to bupivacaine alone in providing comfort
The goal of this prospective open label study is to demonstrate a comparative efficacy/superiority 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).
Comparative efficacy/superiority 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/superiority 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.
Hospital readmission rates
Hospital readmission rates due to device implantation related pain or surgical site infection will be analyzed.
Adverse Effects
Rates of adverse effects, including allergic reaction, worsening of the renal function, presyncope/syncope, HTN, drug-drug interaction or any patient reported side effects will be analyzed.
Cost comparison of medications
Cost of medications will be compared.
Amount of pain medication used
Amount of pain medication used will be analyzed
Click on the lead sponsor to view all of their trials.
Kansas City Heart Rhythm Research Foundation
Lead sponsor
Cardiac Arrhythmia Service, Loma Linda University Health, Loma Linda, CA
Collaborator
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