Pain Management in Cardiac Implantable Electronic Device Insertion; Effectiveness of Bupivacaine, Ketorolac, Ketamine, vs Bupivacaine Alone in Reducing Postoperative Pocket Pain
Kansas City Heart Rhythm Research Foundation
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.
Description
Bupivacaine is a widely used local anesthetic and is often administered by spinal injection prior to major surgical procedures. Ketorolac is a potent NSAID which is used for the short-term relief of moderate to severe pain. It's used for long term duration is generally limited due to its potential to cause GI ulcers/perforation and renal failure. A single dose of perioperative Ketorolac has been found to be effective in reducing opioid consumption. Ketamine is NMDA receptor antagonist and is used for its anesthetic, analgesic, and psychotomimetic effects. It is primarily used for induction and…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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
Interventions
- DrugBupivacaine alone OR Bupivacaine-Ketorolac-Ketamine (BKK) Combination
The plan will be to stratify patients in two groups: intervention group receiving 20 cc combination of BKK (Bupivacaine HCl 60 mg \[3 mg/mL\], Ketorolac Tromethamine 24 mg \[1.2mg/mL\], Ketamine HCl 24 mg \[1.2 mg/mL\]) vs the control group receiving 20 cc of 0.5% bupivacaine (Bupivacaine HCL 100 mg \[5mg/ml\]. The dose can be repeated multiple times during the procedure as per operator's discretion. The patients will be further stratified into sub-groups based on type of procedure they had undergone. Analgesia/anesthesia strategy will be local infiltration of the drug along with a sedating agent based on institutional standard of care. The dose of the medicines will be adjusted as per discretion of the operator to maintain adequate anesthesia/analgesia during and after the procedure.
Locations (3)
- Loma Linda University HealthLoma Linda, California
- Kansas City Heart Rhythm InstituteOverland Park, Kansas
- Overland Park Regional Medical CenterOverland Park, Kansas