Comparing Exparel and Marcaine for Pain Relief After Heart Surgery
Randomized Control Trial to Assess the Efficacy of Preoperative Erector Spinae Blocks on Cardiac Surgery Postoperative Outcomes
This study is testing whether a new pain relief method using Exparel is better than Marcaine for patients recovering from heart surgery.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 1 site (New Brunswick, New Jersey) |
| Trial ID | NCT06077422 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to compare the effectiveness of Ultrasound-Guided Erector Spinae Plane (ESP) Blocks using Exparel® and Marcaine® for managing postoperative pain in patients undergoing cardiac surgeries. The study focuses on reducing postoperative pain to enhance patient satisfaction and minimize complications, such as pneumonia and prolonged ICU stays. By utilizing fascial plane blocks, the study seeks to decrease reliance on high-dose opioids, which are commonly used for pain management but can lead to adverse effects. The research will involve randomizing patients scheduled for mini thoracotomy or open sternotomy to receive either treatment and assess their outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults scheduled for mini thoracotomy or open sternotomy at a single academic medical center.
Not a fit: Patients with chronic pain conditions or those requiring emergent surgery will likely not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve pain management after cardiac surgery, leading to better recovery outcomes and reduced opioid use.
How similar studies have performed: While this approach has shown favorable results in preliminary applications, it has not yet been extensively validated in larger studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New Brunswick, New Jersey
- Rutgers RWJMS — New Brunswick, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Leonard Y Lee, MD — Rutgers Robert Wood Johnson Medical School, Dept of Surgery
- Study coordinator: Leonard Y Lee, MD
- Email: leele@rwjms.rutgers.edu
- Phone: 732-235-9220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.