Exparel vs. Marcaine ESP Block for Post-cardiac Surgical Pain (NCT06077422) | Clinical Trial Compass
By InvitationPhase 2/3
Exparel vs. Marcaine ESP Block for Post-cardiac Surgical Pain
United States150 participantsStarted 2024-01-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Postoperative opioid consumption
Timeframe: Postoperative days 0 through 5
Trial details
NCT IDNCT06077422
SponsorRutgers, The State University of New Jersey