Effectiveness of Bupivacaine, Ketorolac, Ketamine, vs Bupivacaine Alone in Reducing Postoperative… (NCT05575999) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Effectiveness of Bupivacaine, Ketorolac, Ketamine, vs Bupivacaine Alone in Reducing Postoperative Pocket Pain
United States200 participantsStarted 2026-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparative efficacy/superiority of BKK compared to bupivacaine alone in reducing the pain intensity
Timeframe: Upto 1 week
2
Comparative efficacy/superiority of BKK compared to bupivacaine alone in providing comfort
Timeframe: Upto 1 week
3
Comparative efficacy/superiority of BKK compared to bupivacaine alone in Quality of Life (QoL)
Timeframe: Upto 1 week
Trial details
NCT IDNCT05575999
SponsorKansas City Heart Rhythm Research Foundation