Not Yet RecruitingPhase 1ketamine
Effectiveness of Bupivacaine, Ketorolac, Ketamine, vs Bupivacaine Alone in Reducing Postoperative Pocket Pain
Sponsored by Kansas City Heart Rhythm Research Foundation
NCT ID
NCT05575999
Target Enrollment
200 participants
Start Date
2026-01
Est. Completion
2026-12
About This Study
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.
Conditions Studied
Interventions
- •Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) Combination
Eligibility
Age:18 Years - N/A
Healthy Volunteers:Yes
View full eligibility criteria
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
Study Locations (3)
Loma Linda University Health
Loma Linda, California, United States
Kansas City Heart Rhythm Institute
Overland Park, Kansas, United States
Overland Park Regional Medical Center
Overland Park, Kansas, United States