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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorKansas City Heart Rhythm Research Foundation

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Bupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) Combination

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Kansas City Heart Rhythm Research Foundation

Lead sponsor

Cardiac Arrhythmia Service, Loma Linda University Health, Loma Linda, CA

Collaborator