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Effectiveness of Bupivacaine, Ketorolac, Ketamine, vs Bupivacaine Alone in Reducing Postoperative Pocket Pain

StatusNot Yet Recruiting
PhasePhase 1
Started2026-01
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 5 times since 2022-10-07; most recent filed 2025-08-27. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-31.

2025-08-27
Amendment Study Status v5
2024-10-25
Amendment Study Status v4
2024-10-14
Amendment Study Status v3
2023-03-08
Amendment Study Status v2
2022-11-15
Amendment Study Status v1
2022-10-07
Original filing
Trial Details
NCT Number NCT05575999
Lead Sponsor Kansas City Heart Rhythm Research Foundation
Collaborators: Cardiac Arrhythmia Service, Loma Linda University Health, Loma Linda, CA
Conditions Pain Management
Enrollment 200 participants
Start Date 2026-01
Primary Completion 2026-10 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-08-28