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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 belowSelect...
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.
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 moreSide effects data
From 2017 Phase 3 trial • 232 Patients • NCT0271317845%
Motor dysfunction
36%
Nausea
31%
Pyrexia
16%
Constipation
11%
Hypotension
9%
Hepatic enzyme increased
7%
Hypokalemia
7%
Muscle twitching
5%
Hiccups
5%
Headache
5%
Postprocedural hematoma
5%
Vomiting
5%
Pruritus
5%
Fall
4%
Dysgeusia
4%
Dizziness
4%
Urinary retention
3%
Joint swelling
3%
Dyspepsia
3%
Sensory loss
1%
Confusional state
1%
Postprocedural swelling
1%
Cellulitis
1%
Anemia
1%
Insomnia
1%
Atrial fibrillation
1%
Hemoglobin decreased
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
454 Previous Clinical Trials
69,757 Total Patients Enrolled
Pacira Pharmaceuticals, IncIndustry Sponsor
138 Previous Clinical Trials
13,921 Total Patients Enrolled
Leonard Y Lee, MDPrincipal InvestigatorRutgers Robert Wood Johnson Medical School, Dept of Surgery