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NCT05575999 · ClinicalTrials.gov registry record · Phase 1
Effectiveness of Bupivacaine, Ketorolac, Ketamine, vs Bupivacaine Alone in Reducing Postoperative Pocket Pain
A Phase 1 study, sponsored by Kansas City Heart Rhythm Research Foundation.
- Not yet
- Registry status
- Phase 1
- Development phase
- 200
- Enrollment target
NCT05575999: Clinical Trial Phase 1 study, sponsored by Kansas City Heart Rhythm Research Foundation.
NCT05575999 is a Phase 1 study that has not yet begun recruiting, run by Kansas City Heart Rhythm Research Foundation. The registered enrollment target is 200 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (233% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05575999, a Phase 1 study, has not yet begun recruiting, sponsored by Kansas City Heart Rhythm Research Foundation.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 200 participants
- Enrollment target
Study 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.
Primary Outcome
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).
Interventions
- DRUG Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) Combination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2026-01 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What is known before NCT05575999 opens enrollment
NCT05575999 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (233% higher).
The record links to 0 conditions, and to 1 intervention - of which Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) Combination is the first listed.
NCT05575999 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05575999 about?
NCT05575999 is a clinical study titled "Effectiveness of Bupivacaine, Ketorolac, Ketamine, vs Bupivacaine Alone in Reducing Postoperative Pocket Pain". 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 p...
What is the current status of trial NCT05575999?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 200 participants. The study started on 2026-01. Estimated completion is 2026-12.
What interventions are being tested in trial NCT05575999?
The interventions under investigation include: Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) Combination (DRUG).
Who is sponsoring clinical trial NCT05575999?
This trial is sponsored by Kansas City Heart Rhythm Research Foundation, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05575999's enrollment target sits among peer trials
200 259th of 2000 higher than 1,724 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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