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

Trial Summary

What is the purpose of this trial?

This randomized blinded trial aims to evaluate the effect of parasternal intercostal and rectus sheath blocks ("anterior blocks for cardiac surgery" or ABC blocks) on postoperative recovery in patients undergoing median sternotomy for cardiac surgery. Subjects will be randomized to receive either local anesthetic (liposomal bupivacaine plus bupivacaine 0.25%) or saline sham block.

Research Team

Michael Manning, MD

Principal Investigator

Duke University

Eligibility Criteria

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.

Age 18-85 years of age

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

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

Treatment Details

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.

Participant Groups

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+