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ABC Block for Postoperative Pain

Phase 4

Waitlist Available

Led By Michael Manning, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours post-extubation

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will study how a type of pain block affects recovery after heart surgery. Subjects will receive either the block or a dummy block.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include discomfort at the injection site, allergic reactions to the anesthetics used in the ABC blocks such as itching or rash, and less commonly nerve damage which could cause weakness or numbness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours post-extubation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours post-extubation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours post-extubation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Tracheal Extubation

Secondary study objectives

Tracheal Extubation

ICU length of stay

Time from end of case to tracheal extubation

+5 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: ABC block with bupivacaine and liposomal bupivacaineActive Control1 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 salinePlacebo Group1 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).

Do I qualify?Apply below to find out