Bupivacaine vs BKK Combination for Pain Management After CIED Procedures

Recruiting at 2 trial locations

Overseen By Donita Atkins

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Kansas City Heart Rhythm Research Foundation

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of three drugs to manage pain in patients undergoing heart device implant surgeries. The goal is to provide better pain relief than the current standard and avoid using opioids.

Research Team

Dhanunjaya Lakkireddy

Principal Investigator

Kansas City Heart Rhythm Institute

Eligibility Criteria

This trial is for adults over 18 who are getting a new cardiac implantable electronic device (like an ICD or pacemaker) and want to participate. It's not for pregnant/breastfeeding individuals, prisoners, those under 18, anyone allergic to the drugs being tested, or patients considered unstable for the study.

Inclusion Criteria

I am willing to participate in the study.

I am either male or female.

I am older than 18 years.

Exclusion Criteria

Pregnant or breastfeeding patients

I am under 18 years old.

Prisoners

Treatment Details

Interventions

• Bupivacaine (Local Anesthetic Agent)
• Ketamine (NMDA Receptor Antagonist)
• Ketorolac (Nonsteroidal Anti-inflammatory Drug (NSAID))

Trial Overview The study is testing if a mix of Bupivacaine-Ketorolac-Ketamine (BKK) can better manage pain during and after surgery compared to just Bupivacaine alone in patients receiving heart-related implants.

Participant Groups

Group I: Bupivacaine-Ketorolac-Ketamine (BKK) Combination Experimental Treatment 1 Intervention

This is the intervention group of patients receiving 20 cc combination of BKK (Bupivacaine HCl 60 mg \[3 mg/mL\], Ketorolac Tromethamine 24 mg \[1.2mg/mL\], Ketamine HCl 24 mg \[1.2 mg/mL\]).The dose and number of doses of the medicines will be adjusted as per discretion of the operator.

Group II: Bupivacaine Alone Experimental Treatment 1 Intervention

This is the control group of patients receiving 20 cc of 0.5% bupivacaine (Bupivacaine HCL 100 mg \[5mg/ml\] alone. The dose and number of doses of the medicines will be adjusted as per discretion of the operator.

Bupivacaine is already approved in Canada for the following indications:

Approved in Canada as Sensorcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Who Is Running the Clinical Trial?

Kansas City Heart Rhythm Research Foundation

Lead Sponsor

Trials

30

Recruited

14,000+

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

Collaborator

Trials

1

Recruited

200+