Regional Anesthesia for Pediatric Heart Surgery

Overseen By Julia Hoang

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Duke University

Must not be taking: Opioids

Disqualifiers: Sternotomy, Intubation, Chronic pain, 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

Compensation: Varies

Number of Visits: Unknown

Duration: Perioperative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to manage pain after heart surgery in children. One method uses a special ultrasound technique to guide anesthesia, while the other involves surgeons injecting the medicine directly into the wound. The goal is to determine which method provides better pain control. Children under 18 who need heart defect repair and aren't on opioids might be suitable candidates for this trial. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand how it benefits more patients.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on opioid therapy at the time of surgery.

What is the safety track record for these treatments?

Research shows that Ropivacaine, a local anesthetic, is well-tolerated and often used in surgeries. It effectively blocks pain during operations and safely relieves pain after surgery and during childbirth, indicating general safety for humans.

For wound infiltration by surgeons, studies indicate it is safe for both adults and children. This method involves applying the anesthetic directly to the wound area to manage pain, often reducing the need for other pain medications like opioids.

Both treatments in this trial have been used in humans before, demonstrating they are generally well-tolerated and safe. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these anesthesia techniques for pediatric heart surgery because they offer potential improvements in pain management and recovery. Unlike traditional systemic anesthesia, which affects the whole body, regional anesthesia uses ultrasound-guided nerve blocks with ropivacaine, a local anesthetic that targets specific areas, potentially reducing the need for opioids and minimizing side effects. Additionally, the wound infiltration method allows surgeons to deliver the anesthetic directly to the surgical site, offering precise pain control and possibly enhancing healing. These approaches could lead to safer and more comfortable recovery experiences for young patients.

What evidence suggests that this trial's treatments could be effective for pain control following pediatric heart surgery?

In this trial, participants will receive either regional anesthesia with ropivacaine or wound infiltration. Research has shown that ropivacaine effectively relieves pain after heart surgery in children. One study found that using ropivacaine for regional anesthesia reduced pain and the need for opioids after surgery, demonstrating its effectiveness in pain management.

For the wound infiltration arm, studies indicate it also provides good pain relief after surgery. This method delivers the anesthetic directly to the surgical area, reducing the need for additional pain medication. Both methods tested in this trial have shown promise in helping children recover comfortably after heart surgery. ^{2 6 7 8 9}

Who Is on the Research Team?

Lisa M Einhorn, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for children under 18 needing their first surgery to repair a hole in the heart (atrial or ventricular septal defect). They must not be on opioid painkillers, have had previous chest surgery, require breathing support after surgery, or have chronic pain conditions.

Inclusion Criteria

Informed consent / assent provided

My child is under 18 and needs heart defect repair.

Exclusion Criteria

I have been diagnosed with a long-term pain condition.

I am on opioid medication at the time of my surgery.

I will be on a breathing machine after surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ultrasound guided regional anesthesia or surgeon-delivered wound infiltration during pediatric cardiac surgery

Perioperative period

Postoperative Monitoring

Pain intensity and opioid medication usage are monitored for 48 hours after surgery

48 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Ropivacaine 0.2% Injectable Solution
• Wound infiltration

Trial Overview The study compares two ways to manage pain after pediatric heart surgery: using regional anesthesia guided by ultrasound versus surgeon-applied wound numbing with Ropivacaine. It aims to see which method controls pain better.

How Is the Trial Designed?

Group I: Regional Anesthesia Active Control 2 Interventions

Ultrasound guided blocks

Group II: Wound Infiltration Active Control 2 Interventions

Surgeon-delivered wound infiltration

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

The Society of Pediatric Anesthesia

Collaborator

Trials

1

Recruited

50+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11829357/

Regional anesthesia for pediatric cardiac surgery: a review Many studies have demonstrated the efficiency of the ESP block for pediatric cardiac surgery. In an RCT by Gado et al., postoperative opioid ...

2. clinicaltrialsregister.eu clinicaltrialsregister.eu/ctr-search/rest/download/result/attachment/2008-008380-94/1/30808

The effect of continuous wound infusion of ropivacaine on ... in children who undergo cardiac surgery. Methods: This randomized, double-blind study comprised 49 children aged. 1–9 years who underwent atrial septal ...

3. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2022.825945/full

Perioperative Pain Management With Bilateral Pecto- ... Conclusion: Bilateral PIFB in pediatric open cardiac surgical patients provide effective analgesia and lower the length of hospital stay.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11416718/

Pharmacological Insights of Ropivacaine and Clinical ... The article highlights its applications in providing analgesia, prolonging pain relief, and improving recovery outcomes in surgical settings.

5. researchgate.net researchgate.net/publication/327531992_Continuous_Ropivacaine_Infusion_Offers_No_Benefit_in_Treating_Postoperative_Pain_After_Cardiac_Surgery

Continuous Ropivacaine Infusion Offers No Benefit in ... 5 These authors found that a continuous 0.2% ropivacaine infusion offered no difference or benefit in opioid consumption or postoperative pain versus a placebo.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0149291824003291

Analgesic Effects and Pharmacokinetics of Ropivacaine at ... The use of 0.5% ropivacaine is recommended for SAPB to provide satisfactory perioperative analgesia. Abstract. Purpose. Investigate the analgesia effects and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3106379/

Ropivacaine: A review of its pharmacology and clinical use Ropivacaine is a well tolerated regional anaesthetic effective for surgical anaesthesia as well as the relief of postoperative and labour pain.

8. academic.oup.com academic.oup.com/bja/article/90/4/487/274282

Caudal additives in children—solutions or problems? Little effect is seen when it is mixed with bupivacaine 0.5% or 0.75%, yet when mixed with 0.125% or 0.25% the effects of epinephrine are more marked.15 ...

9. withpower.com withpower.com/trial/phase-heart-septal-defects-2-2023-803de

Regional Anesthesia for Pediatric Heart Surgery This Phase 4 medical study run by Duke University needs participants to evaluate whether Ropivacaine 0.2% Injectable Solution will have tolerable side ...