Local Anesthesia for Preventing Atrial Fibrillation After Cardiac Surgery

Overseen By Candace Nelson

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Minnesota

Disqualifiers: Atrial fibrillation, Endocarditis, LVEF < 30%, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if ropivacaine, a local anesthetic, can prevent atrial fibrillation (irregular heartbeat) after heart surgery. Researchers seek to discover whether infusing this drug around the chest area during surgery can maintain regular heartbeats. The trial includes two groups: one will receive ropivacaine, and the other will not. Patients undergoing specific types of heart surgery, such as coronary artery bypass or valve replacement, without a history of atrial fibrillation, may be suitable for this study. As a Phase 4 trial, this research focuses on understanding how an already FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for Ropivacaine?

Research has shown that ropivacaine is generally well-tolerated by patients. In earlier studies, patients who used ropivacaine experienced less pain and expressed high satisfaction with their pain relief. Notably, these studies reported no side effects.

Ropivacaine is a local anesthetic used to numb a specific part of the body during and after surgery. Its use in surgeries suggests it is safe, particularly for pain management. Current research is investigating its potential to prevent atrial fibrillation (an irregular heartbeat) after heart surgery without adding significant risks.

As this trial is in an advanced stage, past trials and uses have likely documented ropivacaine's safety. However, discussing individual risks and benefits with a healthcare provider remains important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for preventing atrial fibrillation after cardiac surgery focus on medications like beta-blockers, amiodarone, or anticoagulants. But ropivacaine works differently, acting as a local anesthetic to numb the nerves around the heart. This method could reduce the risk of atrial fibrillation by directly targeting the nerves responsible for triggering irregular heartbeats, offering a potentially safer and more focused alternative without the systemic side effects of traditional drugs. Researchers are excited because it represents a novel approach that could improve patient outcomes and recovery times.

What evidence suggests that ropivacaine might be an effective treatment for preventing atrial fibrillation after cardiac surgery?

Research has shown that ropivacaine, a local pain reliever, can lower the risk of irregular heartbeats after heart surgery. In this trial, participants in the experimental group will receive ropivacaine to assess its effectiveness in preventing irregular heartbeats. One study found that patients who received ropivacaine experienced fewer cases of irregular heartbeats than those who did not. Another study confirmed that using ropivacaine is both effective and safe for preventing this heart issue. As this is a Phase 4 trial, ropivacaine has already been proven effective for other uses. These findings suggest that ropivacaine could help prevent irregular heartbeats after heart surgery. ^{3 5 6 7 8}

Who Is on the Research Team?

James Flaherty, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults needing certain heart surgeries (CABG, aortic or mitral valve replacement) without emergency conditions. Candidates must not have had atrial fibrillation before, severe heart pump dysfunction, an allergy to local anesthetics, bleeding disorders, be severely overweight or pregnant.

Inclusion Criteria

I am scheduled for heart surgery, such as bypass or valve replacement.

Exclusion Criteria

I cannot have block placement due to an allergy to local anesthetics or bleeding issues.

I have a history of irregular heartbeats.

I have been diagnosed with an infection in the heart's inner lining.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-Surgery Preparation

Placement of ultrasound guided bilateral T3 paravertebral catheters and administration of lidocaine and epinephrine

1 day

1 visit (in-person)

Surgery and Immediate Post-Operative Care

Participants undergo cardiac surgery with ropivacaine administered via catheters during and after surgery

5 days

Continuous monitoring in hospital

Follow-up

Participants are monitored for safety and effectiveness, including incidence of new-onset atrial fibrillation and other secondary outcomes

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Ropivacaine

Trial Overview The study tests if injecting Ropivacaine (a numbing medication) near the spine before and after surgery can prevent new cases of irregular heartbeat (atrial fibrillation) in patients having their first bypass or heart valve surgery.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

Participants in this group will receive the intervention.

Group II: Control Active Control 1 Intervention

Participants in this group will receive no intervention.

Ropivacaine is already approved in European Union, United States, Canada, China for the following indications:

Approved in European Union as Naropin for:

• Surgical anesthesia
• Pain relief

Approved in United States as Naropin for:

• Surgical anesthesia
• Pain relief

Approved in Canada as Naropin for:

• Surgical anesthesia
• Pain relief

Approved in China as Naropin for:

• Surgical anesthesia
• Pain relief

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

Ropivacaine is a long-acting local anesthetic that has been shown to have a better safety profile than bupivacaine, particularly with reduced cardiovascular toxicity, making it a safer option for various medical procedures.

It is equally effective as bupivacaine for different types of anesthesia, such as epidural and nerve blocks, but causes less motor block, which is beneficial in settings like obstetrics and pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ropivacaine: a pharmacological review. Hansen, TG.[2018]

In a study of 112 children undergoing surgery, ropivacaine combined with fentanyl provided longer-lasting pain relief compared to bupivacaine with fentanyl, with the first need for rescue analgesics occurring 6.1 hours for ropivacaine versus 5.6 hours for bupivacaine.

Ropivacaine demonstrated better hemodynamic stability and reduced need for inhalational anesthetics during surgery, making it a safer option for pediatric patients undergoing below-umbilical surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of ropivacaine and bupivacaine with fentanyl for caudal epidural in pediatric surgery. Doctor, TP., Dalwadi, DB., Abraham, L., et al.[2020]

Ropivacaine, a long-acting local anesthetic, is safer than bupivacaine, showing less cardiovascular and central nervous system toxicity, making it a preferable option for various types of anesthesia.

While ropivacaine provides similar sensory block effects as bupivacaine, it causes less motor block, which may be beneficial in certain surgical situations, although its higher cost could limit its use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ropivacaine. Owen, MD., Dean, LS.[2022]

Ropivacaine is a long-acting local anesthetic that effectively blocks nerve signals by inhibiting sodium ion influx, making it suitable for surgical anesthesia and pain relief during and after surgery.

Compared to bupivacaine, ropivacaine has a similar efficacy for nerve blocks but is associated with a lower risk of motor block and reduced potential for central nervous system and cardiac toxicity, making it a safer option for regional anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ropivacaine: a review of its use in regional anaesthesia and acute pain management. Simpson, D., Curran, MP., Oldfield, V., et al.[2022]

In a study of 52 patients undergoing ACL reconstruction, the combination of ropivacaine and fentanyl provided better pain relief compared to ropivacaine and clonidine, as indicated by lower VAS scores at 8 hours post-operation.

Patients receiving the clonidine combination required more total analgesic solution and experienced greater motor blockade, as shown by higher Bromage scores, suggesting that fentanyl may be a more effective adjuvant for postoperative analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between ropivacaine 1.5 mg ml(-1) plus fentanyl 2 mg ml(-1) and ropivacaine 1.5 mg ml(-1) plus clonidine 1 mg ml(-1) as analgesic solution after anterior cruciate ligament reconstruction: a randomized clinical trial. Apostolos, K., Georgios, K., Omiros, C., et al.[2018]

In a study of 70 adult patients undergoing minimally invasive cardiac surgery, the use of 0.2% ropivacaine wound infusion via a PCA pump significantly reduced the cumulative opioid dose needed in the first 48 hours post-surgery, with a median of 3 mg compared to 9 mg in the control group.

Patients receiving ropivacaine also experienced fewer episodes of pain (NRS scores >3) and reported high satisfaction with pain relief, with no reported side effects from the local anesthetic, indicating its safety and efficacy as part of a multimodal pain management strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of wound infusion of 0.2% ropivacaine by patient control analgesia pump after minithoracotomy aortic valve replacement: a randomized, double-blind, placebo-controlled trial. Mijovski, G., Podbregar, M., Kšela, J., et al.[2021]

Patients receiving continuous regional infusion of ropivacaine after median sternotomy for cardiac surgery experienced significantly lower postoperative pain scores and required less narcotic analgesia compared to those receiving saline, with total narcotic use of 47.3 mg versus 78.7 mg (P = 0.038).

The use of ropivacaine also led to a reduced hospital length of stay, averaging 5.2 days compared to 8.2 days for the saline group (P = 0.001), indicating potential cost savings and improved recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved pain control after cardiac surgery: results of a randomized, double-blind, clinical trial. Dowling, R., Thielmeier, K., Ghaly, A., et al.[2019]

Citations

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Postoperative atrial fibrillation: from mechanisms to treatment Available evidence shows that POAF is strongly associated with increased rates of adverse cardiovascular outcomes; nevertheless, POAF is also an early predictor ...

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Autonomic Neuromodulation for Atrial Fibrillation Following ... Temporary spinal cord stimulation to prevent post-cardiac surgery atrial fibrillation: 30-day safety and efficacy outcomes. J Am Coll ...