ABC Block for Postoperative Pain

Overseen By Jeff Gadsden, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Duke University

Must not be taking: Opioids, Illicit drugs, Alcohol

Disqualifiers: Severe pulmonary disease, Neurological disorder, 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: 1

Duration: Day of surgery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to ease pain after heart surgery using a treatment called an ABC block, where medicine is injected near the chest to alleviate pain. Participants will receive either a mix of pain-relief medicine (bupivacaine) or a harmless saline solution for comparison. Those scheduled for heart surgery with a midline chest incision may qualify for this trial. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, aiming to understand its benefits for more patients.

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

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 these treatments?

A previous study showed that liposomal bupivacaine reduces pain and the need for strong painkillers after surgery. Research shows that liposomal bupivacaine is generally safe for numbing specific areas of the body. Common side effects include nausea and itching, while serious issues like heart or lung problems are rare. These findings suggest that most patients tolerate the treatment well, making it a potentially safe option for managing post-surgical pain. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the ABC block for postoperative pain because it incorporates liposomal bupivacaine, which allows for a sustained release of the anesthetic, potentially providing longer-lasting pain relief compared to standard options. Traditional treatments often rely on shorter-acting local anesthetics, which may require more frequent dosing. The ABC block is administered as a bilateral parasternal and epigastric rectus sheath block, targeting specific areas to enhance pain control. By combining liposomal bupivacaine with standard bupivacaine, this treatment aims to improve comfort and reduce the need for additional pain medications post-surgery.

What evidence suggests that this trial's treatments could be effective for postoperative pain?

Research shows that combining bupivacaine with liposomal bupivacaine helps manage post-surgical pain. In this trial, one group of participants will receive the ABC block with this combination. Studies have found that patients receiving this combination report less pain and require fewer opioids in the initial days after surgery. Specifically, liposomal bupivacaine can reduce opioid use without increasing pain, which aids recovery. While some results vary, most suggest better pain relief compared to standard bupivacaine alone. This combination is increasingly used to control post-surgical pain, making it a promising option for heart surgery patients. Another group in this trial will receive the ABC block with saline as a comparator. ^{2 6 7 8 9}

Who Is on the Research Team?

Michael Manning, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 undergoing elective cardiac surgery via median sternotomy, with a BMI of 18-50 kg/m2. It's not suitable for those with severe lung disease, very weak heart function (LVEF <30%), certain pre/post-operative conditions, drug or alcohol abuse history, chronic opioid use, amide anesthetic allergy, or major psychiatric disorders.

Inclusion Criteria

Subjects scheduled for elective cardiac surgery involving primary median sternotomy

Your body mass index (BMI) is between 18 and 50, which means you are within a healthy weight range for your height.

Exclusion Criteria

You have a problem with your brain or nervous system that affects how your body works.

Severe pulmonary disease

Left ventricular ejection fraction (LVEF) < 30%

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either ABC blocks with bupivacaine or saline sham blocks during cardiac surgery

Day of surgery

1 visit (in-person)

Postoperative Monitoring

Evaluation of acute postoperative pain intensity and opioid consumption at 24 and 48 hours postoperatively

48 hours

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including ICU and hospital length of stay

3 days

What Are the Treatments Tested in This Trial?

Interventions

• ABC block with bupivacaine/liposomal bupivacaine
• ABC block with saline

Trial Overview The study tests the effectiveness of ABC blocks in pain management after cardiac surgery. Participants will be randomly assigned to receive either a local anesthetic (bupivacaine plus liposomal bupivacaine) or a saline sham block to compare recovery outcomes.

How Is the Trial Designed?

Group I: ABC block with bupivacaine and liposomal bupivacaine Active Control 1 Intervention

The study solution used in the active arm will comprise 20 mL of liposomal bupivacaine (266 mg) admixed with 40 mL of 0.25% bupivacaine HCl. The solution will be administered as bilateral parasternal blocks (40 mL) and bilateral epigastric rectus sheath blocks (20 mL).

Group II: ABC block with saline Placebo Group 1 Intervention

The study solution used in the active arm will comprise 60 mL of 0.9% saline. The solution will be administered as bilateral parasternal blocks (40 mL) and bilateral epigastric rectus sheath blocks (20 mL).

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33372949/

Clinical Effectiveness of Liposomal Bupivacaine ... Ninety-two percent of trials (11 of 12) suggested a peripheral nerve block with unencapsulated bupivacaine provides superior analgesia to infiltrated liposomal ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1058274622003445

Efficacy of liposomal bupivacaine for pain control in ... The outcome measures for our meta-analysis were visual analog scale (VAS) pain scores at 24 and 48 hours after surgery, opioid consumption 24 and 48 hours after ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33273351/

The Efficacy of Liposomal Bupivacaine on Postoperative ... We hypothesized that liposomal bupivacaine plane block would result in decreased opioid requirements compared with placebo in the first 72 hours after surgery.

4. journals.sagepub.com journals.sagepub.com/doi/10.1177/10600280211043554

Liposomal Bupivacaine Versus Immediate-Release ... Liposomal bupivacaine (LB) is increasingly being used for postoperative pain control, but there are conflicting efficacy data when compared with immediate- ...

5. arthroplasty.biomedcentral.com arthroplasty.biomedcentral.com/articles/10.1186/s42836-023-00226-y

A prospective, randomized trial of liposomal bupivacaine ... The study demonstrated that LB ACBs led to significantly lower opioid consumption in the days following TKA without affecting pain scores or length of stay.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10158925/

Clinical Outcomes of Liposomal Bupivacaine Erector ... Liposomal bupivacaine (LB) has been shown to decrease postoperative pain and narcotic consumption after transforaminal lumbar interbody fusions ...

7. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/10600280211043554

Liposomal Bupivacaine Versus Immediate-Release ... The primary outcome was total opioid consumption within 24 hours postoperatively. Secondary outcomes included total opioid consumption within 72 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12443838/

Liposomal bupivacaine intercostal nerve block for pain control ... Safety outcomes included the incidence of postoperative nausea and vomiting (PONV), pruritus, pulmonary complications, and cardiovascular events ...

9. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1359878/full

Effect of liposomal bupivacaine for preoperative erector ... Liposome bupivacaine appears safe when used in fascial plane blocks and peripheral nerve blocks (16–20). Whether LB is superior to traditional local anesthetics ...