Bupivacaine vs BKK Combination for Pain Management After CIED Procedures

Recruiting at 2 trial locations

Overseen By Donita Atkins

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Kansas City Heart Rhythm Research Foundation

Disqualifiers: Allergies, Pregnancy, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Bupivacaine for pain management after CIED procedures?

Research shows that Bupivacaine (also known as Marcaine or Sensorcaine) is effective in managing pain after surgeries, such as breast reduction and lumbar disc surgery, due to its long-lasting pain relief and minimal side effects. ^{1 2 3 4 5}

Is the Bupivacaine and BKK combination generally safe for humans?

Bupivacaine (also known as Marcaine or Sensorcaine) is generally considered safe when used in recommended doses, with minimal side effects reported in various medical procedures. It has been used effectively in obstetrics and surgery with limited side effects, especially when doses are carefully controlled. ^{3 4 5 6 7}

What makes the drug Bupivacaine unique for pain management after CIED procedures?

Bupivacaine is unique because it offers a longer duration of pain relief compared to other local anesthetics, which can be beneficial for managing pain after CIED (cardiac implantable electronic device) procedures. It also has a favorable balance between effectiveness and safety, making it a preferred choice in various surgical settings. ^{2 5 8 9 10}

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Bupivacaine alone or a combination of Bupivacaine-Ketorolac-Ketamine (BKK) during the CIED insertion procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain intensity, quality of life, and adverse effects post-procedure

1 week

1-2 visits (in-person or virtual)

Treatment Details

Interventions

• Bupivacaine
• Ketamine
• Ketorolac

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 United States, European Union, Canada for the following indications:

Approved in United States as Marcaine for:

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

Approved in European Union as Marcaine for:

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

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+

Findings from Research

Bupivacaine hydrochloride (Marcaine) is highlighted for its increased duration of action compared to other local anesthetics, making it particularly useful in oral surgery.

It also has a favorable potency to toxicity ratio, suggesting that it provides effective pain relief with a lower risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine: a review. Babst, CR., Gilling, BN.[2018]

In a study of 37 patients undergoing breast reduction surgery, the use of the long-acting local anesthetic bupivacaine (Sensorcaine) significantly reduced the time to discharge from the postanesthesia care unit, averaging 2.9 hours compared to 3.8 hours for the placebo group.

Patients who received Sensorcaine reported lower pain levels and required significantly less narcotic medication post-surgery, taking an average of 3.5 tablets compared to 6.4 tablets in the control group, indicating its efficacy in managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative Sensorcaine significantly improves postoperative pain management in outpatient reduction mammaplasty. Culliford, AT., Spector, JA., Flores, RL., et al.[2021]

Bupivacaine (Marcaine) is effective for epidural analgesia in obstetrics, providing excellent sensory block with minimal impact on motor function and few side effects for both mothers and newborns.

When used at concentrations below 0.5%, and with careful dosing during labor, the risk of side effects and toxicity is low, and significant effects on newborns are rare due to the drug's high protein binding limiting its transfer across the placenta.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. Seebacher, J., Chareire, F., Galli-Douant, P., et al.[2013]

In a study involving 30 patients, two forms of 0.5% bupivacaine hydrochloride (Anecaine and Marcaine) were compared for epidural anesthesia, revealing differences in how quickly and effectively they provided pain relief.

Anecaine showed a shorter onset of analgesia at the catheter site but a delayed effect in peripheral areas compared to Marcaine, indicating that even the same active ingredient can behave differently based on the manufacturer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A clinical trial of the use of 2 forms of bupivacaine hydrochloride (Anecaine and Marcaine) for epidural anesthesia]. Kozlov, SP., Vashchinskaia, TV., Svetlov, VA.[2013]

Bupivacaine with a vasoconstrictor has a shorter onset time for local anesthesia compared to bupivacaine without a vasoconstrictor, but the duration of anesthesia is longer without the vasoconstrictor.

Using bupivacaine without a vasoconstrictor resulted in lower postoperative pain levels and better blood circulation, which is beneficial for the osseointegration of dental implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. Duka, M., Lazić, Z., Stamatović, N., et al.[2019]

References

1. India pubmed.ncbi.nlm.nih.gov

Preventive Effects of Pre- and Intra-operative Marcaine, Lidocaine, and Marcaine Plus Lidocaine on Pain Relief in Lumbar Disc Herination Open Surgery. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Bupivacaine: a review. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Intraoperative Sensorcaine significantly improves postoperative pain management in outpatient reduction mammaplasty. [2021]

4. France pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. [2013]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[A clinical trial of the use of 2 forms of bupivacaine hydrochloride (Anecaine and Marcaine) for epidural anesthesia]. [2013]

6. Serbia pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Hemodynamic and cardiac electrophysiologic effects of lidocaine-bupivacaine mixture in anesthetized and ventilated piglets. [2022]

8. France pubmed.ncbi.nlm.nih.gov

A prospective study comparing the analgesic efficacy of levobupivacaine, ropivacaine and bupivacaine in pediatric patients undergoing caudal blockade. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Comparison of the effect of ketamine added to bupivacaine and ropivacaine, on stress hormone levels and the duration of caudal analgesia. [2018]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

The safety of a mixture of bupivacaine and lidocaine in children after urologic inguinal and scrotal surgery. [2019]