What side effects are associated with this type of intervention?

Common treatments for pain management, particularly those similar to the Bupivacaine-Ketorolac-Ketamine (BKK) combination, have specific side effects. Bupivacaine, a local anesthetic, can cause dizziness, hypotension, and in severe cases, cardiac arrest or central nervous system toxicity. Ketorolac, an NSAID, is associated with gastrointestinal issues like ulcers and bleeding, renal impairment, and increased risk of cardiovascular events. Ketamine, an NMDA receptor antagonist, can cause psychological effects such as hallucinations, confusion, and in some cases, increased intracranial pressure and respiratory depression. Combining these agents may enhance analgesic efficacy but also requires careful monitoring for these potential side effects.

What prior FDA approvals exist?

The FDA has approved several drugs for pain management that are similar to the components of the Bupivacaine-Ketorolac-Ketamine (BKK) combination. Bupivacaine, a local anesthetic, is widely used for surgical anesthesia and postoperative pain control. Ketorolac, an NSAID, is approved for short-term management of moderate to severe pain, often used postoperatively. Ketamine, an NMDA receptor antagonist, is approved for anesthesia and has been used off-label for chronic pain management. These drugs, individually approved by the FDA, are commonly used in various combinations to enhance pain relief in clinical settings.

What other types of research exist?

Promising alternatives to BKK for pain management include: 1) Intravenous acetaminophen, which has shown effectiveness in reducing perioperative opioid use and improving pain control. 2) Intranasal ketorolac, a newer NSAID option that provides effective analgesia. 3) Dexmedetomidine, an alpha-2 adrenergic agonist, which has been effective in enhancing postoperative analgesia and reducing perioperative stress. 4) Topical menthol, which has demonstrated rapid symptomatic improvement in neuropathic pain. 5) Capsaicin 8% dermal patch, which has shown efficacy in managing chronic neuropathic pain.

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Local Anesthetic Agent

Bupivacaine vs BKK Combination for Pain Management After CIED Procedures

Phase 1

Waitlist Available

Led By Dhanunjaya Lakkireddy, MD

Research Sponsored by Kansas City Heart Rhythm Research Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until 7 days (until the end of the sutdy)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include discomfort at the injection site, nausea, dizziness from Bupivacaine; stomach issues and bleeding risk from Ketorolac; and altered mental state or hallucinations from Ketamine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until 7 days (until the end of the sutdy)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until 7 days (until the end of the sutdy)

This trial's timeline: 3 weeks for screening, Varies for treatment, and until 7 days (until the end of the sutdy) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bupivacaine

Secondary study objectives

Adverse Effects

Pharmaceutical Preparations

Cost comparison of medications

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Bupivacaine-Ketorolac-Ketamine (BKK) CombinationExperimental Treatment1 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 AloneExperimental Treatment1 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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Local anesthetics like bupivacaine work by blocking sodium channels on nerve cells, preventing the transmission of pain signals to the brain. NSAIDs such as ketorolac inhibit cyclooxygenase enzymes (COX-1 and COX-2), reducing the production of prostaglandins that cause inflammation and pain. NMDA receptor antagonists like ketamine block NMDA receptors in the central nervous system, which are involved in the amplification of pain signals. These mechanisms are crucial for pain management patients as they target different pathways in the pain signaling process, providing a multimodal approach that can enhance pain relief and reduce the need for opioids, thereby minimizing potential side effects and dependency.

Ketorolac, a new non-opioid analgesic: a double-blind trial versus pentazocine in cancer pain.Opioid-sparing effects of ketorolac in palliative care patients receiving opioids for chronic cancer-related pain: A systematic literature review.Topical Ketamtene: A REVIEW OF THE HISTORY, MECHANISMS, USES, SAFETY, AND FUTURE.