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

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kansas City Heart Rhythm Research Foundation
• Collaborator: Cardiac Arrhythmia Service, Loma Linda University Health, Loma Linda, CA
• Treatments: Bupivacaine; Ketamine; Ketorolac

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