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Exparel for Heart Disease

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Postoperative opioid consumption

Secondary outcome measures

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

Hiccups

Postprocedural hematoma

Headache

Vomiting

Pruritus

Fall

Dizziness

Dysgeusia

Urinary retention

Dyspepsia

Sensory loss

Joint swelling

Insomnia

Anemia

Confusional state

Postprocedural swelling

Cellulitis

Hemoglobin decreased

Atrial fibrillation

100%

80%

60%

40%

20%

Study treatment Arm

EXPAREL 133 mg

EXPAREL 266 mg

Placebo

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

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,112 Total Patients Enrolled

Pacira Pharmaceuticals, IncIndustry Sponsor

136 Previous Clinical Trials

13,913 Total Patients Enrolled

Leonard Y Lee, MDPrincipal InvestigatorRutgers Robert Wood Johnson Medical School, Dept of Surgery

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this study currently open?

"Indeed, the details provided on clinicaltrials.gov indicate that this study is actively seeking participants. The trial was initially posted on January 11th, 2024 and last updated on January 24th, 2024. A total of 120 individuals will be enrolled in this trial across one site."

Answered by AI

What is the upper limit for the number of participants involved in this medical study?

"Indeed, the data available on clinicaltrials.gov indicates that this research endeavor is actively seeking suitable participants. The trial was publicly posted on January 11th, 2024 and has been recently updated as of January 24th, 2024. A total of 120 patients are being sought for enrollment at a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Exparel vs. Marcaine ESP Block for Post-cardiac Surgical Pain

Leonard Y. Lee, MD 2024. "Exparel vs. Marcaine ESP Block for Post-cardiac Surgical Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06077422.

All > Surgery