Overview

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

Status:
Recruiting
Trial end date:
2025-04-05
Target enrollment:
0
Participant gender:
All
Summary
The goal of this pilot study is to describe and compare Ultrasound-Guided Erector Spinae Plane (ESP) Blocks using Exparel® (bupivacaine liposome injectable suspension) to Marcaine® (bupivacaine hydrochloride) for pain management and outcomes after cardiac surgeries.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborator:
Pacira Pharmaceuticals, Inc
Treatments:
Bupivacaine
Criteria
Inclusion Criteria:

- Adults (18 years-no upper age limit)

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

Exclusion Criteria:

Patients will be excluded if they:

- Are currently on pain medication or pain regimen for chronic pain condition

- Convert to sternotomy (for thoracotomies)

- Require, upon intraoperative discovery and surgeon's decision, the need for an
unplanned secondary procedure other than the originally scheduled index operation

- Undergo emergent surgery

- Are non-English speaking (The majority of the PI's patient population speak English.
As a pilot study the investigators cannot afford to enroll non-English speaking
subjects due to time, personnel, and financial constraints.)

- Mechanical circulatory support (MCS)

- Vasoactive medications

- Intubated

- Active infection

- Patients otherwise deemed ineligible for ESP block by the investigators due to safety
concerns.