Status:
RECRUITING
Exparel vs. Marcaine ESP Block for Post-cardiac Surgical Pain
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
Pacira Pharmaceuticals, Inc
Conditions:
Pain, Postoperative
Opioid Use
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 hydroc...
Detailed Description
Postoperative pain is a major concern for patients after cardiovascular surgery. With an increasing emphasis on improving perioperative care arising from evidence-based protocols such as Enhanced Rec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 5 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06077422
Start Date
January 11 2024
End Date
April 5 2025
Last Update
January 26 2024
Active Locations (1)
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1
Rutgers RWJMS
New Brunswick, New Jersey, United States, 08903