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

Pain Management

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

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Donita Atkins
CONTACT
816-651-1969datkins@kchrf.com
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source