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Exparel vs. Marcaine for Postoperative Pain After Heart Surgery

Phase 2 & 3

Recruiting

Led By Leonard Y Lee, MD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

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

Must have

Scheduled for mini thoracotomy (i.e. valve repair) or open sternotomy (i.e. bypass graft) at single academic medical center (in and out-patients).

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study duration, limited to one year.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare two types of pain management techniques after cardiac surgeries: Ultrasound-Guided Erector Spinae Plane (ESP) Blocks using Exparel® and Marcaine®.

Who is the study for?

This trial is for adults of any age who are scheduled for certain heart surgeries like valve repair or bypass graft at a specific academic medical center. It's not suitable for people outside this setting.

What is being tested?

The study compares two pain management drugs after heart surgery: Exparel (a long-acting form of bupivacaine) and Marcaine (a standard form), both administered via an ultrasound-guided Erector Spinae Plane Block.

What are the potential side effects?

Possible side effects include local reactions at the injection site, nausea, vomiting, headache, fever, and backache. There may also be risks associated with nerve blocks such as numbness or weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for a chest surgery at a specific academic medical center.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study duration, limited to one year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study duration, limited to one year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and study duration, limited to one year. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Postoperative opioid consumption

Secondary study objectives

30-day major morbidity rate

30-day mortality rate

Hospitalization cost

+4 more

Side effects data

From 2017 Phase 3 trial • 232 Patients • NCT02713178

45%

Motor dysfunction

36%

Nausea

31%

Pyrexia

16%

Constipation

11%

Hypotension

Hepatic enzyme increased

Hypokalemia

Muscle twitching

Headache

Postprocedural hematoma

Hiccups

Vomiting

Pruritus

Fall

Dysgeusia

Dizziness

Urinary retention

Joint swelling

Dyspepsia

Sensory loss

Confusional state

Postprocedural swelling

Cellulitis

Anemia

Insomnia

Atrial fibrillation

Hemoglobin decreased

100%

80%

60%

40%

20%

Study treatment Arm

EXPAREL 133 mg

EXPAREL 266 mg

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ExparelExperimental Treatment1 Intervention

The experimental medication (Exparel) will be administered per standard of care via ultrasound-guided erector spinae plane (ESP) blocks, bilaterally for sternotomy and unilaterally for mini-thoracotomy. The drug will be administered prior to cardiac surgery. The dosage will be determined by patient body weight. For this pilot project the investigators anticipate consenting 120 subjects to obtain 96 evaluable subjects; 48 Mini thoractomies (N=24 Exparel, N=24 Marcaine) 48 Open sternotomies (N=24 Exparel, N=24 Marcaine).

Group II: MarcaineActive Control1 Intervention

The active comparator medication (Marcaine) will be administered per standard of care via ultrasound-guided erector spinae plane (ESP) blocks, bilaterally for sternotomy and unilaterally for mini-thoracotomy. The drug will be administered prior to cardiac surgery. The dosage will be determined by patient body weight. For this pilot project the investigators anticipate consenting 120 subjects to obtain 96 evaluable subjects; 48 Mini thoracotomies (N=24 Exparel, N=24 Marcaine) 48 Open sternotomies (N=24 Exparel, N=24 Marcaine).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

bupivacaine liposome injectable suspension

2016

Completed Phase 4

~710

0 / 1Eligibility criteria met