Local Anesthesia for Preventing Atrial Fibrillation After Cardiac Surgery
Recruiting in Palo Alto (17 mi)
Overseen byJames Flaherty, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Minnesota
Disqualifiers: Atrial fibrillation, Endocarditis, LVEF < 30%, others
No Placebo Group
Prior Safety Data
Approved in 4 Jurisdictions
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.
12345How 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.
23467Eligibility 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.
+5 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
Participants in this group will receive the intervention.
Group II: ControlActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MinnesotaMinneapolis, MN
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Who Is Running the Clinical Trial?
University of MinnesotaLead Sponsor
References
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]Local anesthetic wound infusion has become an invaluable technique in multimodal analgesia. The effectiveness of wound infusion of 0.2% ropivacaine delivered by patient controlled analgesia (PCA) pump has not been evaluated in minimally invasive cardiac surgery. We tested the hypothesis that 0.2% ropivacaine wound infusion by PCA pump reduces the cumulative dose of opioid needed in the first 48 h after minithoracothomy aortic valve replacement (AVR).
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]Ropivacaine is commonly used as local anesthetic for postoperative analgesia through an epidural catheter. Data show that several adjuvants influence the analgesic effect of local anesthetic potency.
Ropivacaine. [2022]Ropivacaine (Naropin, AstraZeneca) is a long-acting amide local anaesthetic released for clinical use in 1996. Similar to bupivacaine, ropivacaine is equally effective for s.c. infiltration, epidural and peripheral nerve block for surgery, obstetric and post-operative analgesia. Ropivacaine differs from most other amide-type local anaesthetics in that it is marketed as a pure S-enantiomer, instead of as a racemate. This feature improves the safety of ropivacaine, and, indeed, studies have shown ropivacaine to have less cardiovascular and CNS toxicity than bupivacaine. Ropivacaine is nearly identical to bupivacaine in onset, quality and duration of sensory block, but it produces less motor block. Whether or not the motor sparing effect of ropivacaine is due to a lower relative potency compared to bupivacaine is a matter of intense debate. Despite a better safety profile, the increased cost of ropivacaine may limit its clinical utility.
Ropivacaine: a review of its use in regional anaesthesia and acute pain management. [2022]Ropivacaine (Naropin) is the pure S(-)-enantiomer of propivacaine, and is a long-acting amide local anaesthetic agent, eliciting nerve block via reversible inhibition of sodium ion influx in nerve fibres. Ropivacaine is a well tolerated regional anaesthetic effective for surgical anaesthesia as well as the relief of postoperative and labour pain. The efficacy of ropivacaine is similar to that of bupivacaine and levobupivacaine for peripheral nerve blocks and, although it may be slightly less potent than bupivacaine when administered epidurally or intrathecally, equi-effective doses have been established. Clinically adequate doses of ropivacaine appear to be associated with a lower incidence or grade of motor block than bupivacaine. Thus ropivacaine, with its efficacy, lower propensity for motor block and reduced potential for CNS toxicity and cardiotoxicity, appears to be an important option for regional anaesthesia and for the management of postoperative and labour pain.
Improved pain control after cardiac surgery: results of a randomized, double-blind, clinical trial. [2019]We sought to determine whether a continuous regional infusion of a local anesthetic delivered to the operative site would result in decreased levels of postoperative pain and narcotic requirements for patients who undergo a standard median sternotomy for cardiac surgery.
Ropivacaine: a pharmacological review. [2018]Ropivacaine (Naropin, AstraZeneca) a new long-acting amide local anaesthetic agent, is a pure S-enantiomer, with a high pKa and relatively low-lipid solubility. Since its clinical introduction in 1996, it has been the focus of intense interest because of its increased CNS and cardiovascular safety compared with bupivacaine. This article reviews the pharmacology of ropivacaine with particular emphasis placed on toxicological issues. Compared with bupivacaine (the drug of choice for many years), ropivacaine is equally effective for subcutaneous infiltration, epidural, intrathecal and peripheral nerve block surgery, and obstetrics and postoperative analgesia. Ropivacaine is virtually identical to bupivacaine in terms of onset, quality and duration of sensory block, but seems to produce less motor block. The lesser toxicity of ropivacaine compared with bupivacaine has been confirmed in numerous animal experiments as well as human studies, including studies considering the presumed lower potency of ropivacaine. In fact, the reduced cardiovascular toxicity compared with bupivacaine may be a distinct feature of ropivacaine. So far, the increased cost of ropivacaine compared with bupivacaine has limited its wider clinical use -- in spite of the improved safety profile. During the last few years, cost differences between bupivacaine and ropivacaine have been minimized, thus making pharmacoeconomical speculations a much lesser concern when choosing a local anaesthetic drug. In conclusion, ropivacaine appears to be a safer local anaesthetic agent than bupivacaine. It seems particularly indicated for major peripheral nerve blocks and obstetrics. Ropivacaine should be considered when regional blocks are used in neonates and young infants. With the current trend in the cost development, ropivacaine will most likely be used increasingly in the future.
Comparison of ropivacaine and bupivacaine with fentanyl for caudal epidural in pediatric surgery. [2020]Ropivacaine, s-enantiomer of amide local anaesthetic produces differential neural blockade with less motor blockade, cardiovascular and neurological toxicity makes it suitable for day case surgery in children.