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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose if this pilot study is to determine if a perioperative infusion of 0.2% ropivacaine via bilateral T3 paravertebral catheters can decrease the incidence of new onset atrial fibrillation following primary CABG and/or valve surgery and compare a number of secondary outcomes.

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 Ropivacaine (Naropin) for preventing atrial fibrillation after cardiac surgery?

Ropivacaine is a long-acting local anesthetic that has been shown to be effective for pain relief in various surgical settings, including cardiac surgery, by reducing the need for opioids and improving pain control. Its safety profile is better than similar drugs, with less risk of heart and nervous system side effects. ^{1 2 3 4 5}

How does the drug Ropivacaine differ from other treatments for preventing atrial fibrillation after cardiac surgery?

Ropivacaine is unique because it is a local anesthetic that is safer for the heart and nervous system compared to similar drugs like bupivacaine, making it potentially beneficial for preventing atrial fibrillation after cardiac surgery. It is marketed as a pure S-enantiomer, which contributes to its lower toxicity and reduced risk of side effects. ^{2 3 4 6 7}

Research Team

James Flaherty, MD

Principal Investigator

University of Minnesota

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England 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. [2021]

2. Lebanon 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. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Ropivacaine. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Ropivacaine: a review of its use in regional anaesthesia and acute pain management. [2022]

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

Improved pain control after cardiac surgery: results of a randomized, double-blind, clinical trial. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Ropivacaine: a pharmacological review. [2018]

7. India pubmed.ncbi.nlm.nih.gov

Comparison of ropivacaine and bupivacaine with fentanyl for caudal epidural in pediatric surgery. [2020]