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

Randomized Control Trial to Assess the Efficacy of Preoperative Erector Spinae Blocks on Cardiac Surgery Postoperative Outcomes

Status
Enrolling by invitation
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06077422
Enrollment
150
Registered
2023-10-11
Start date
2024-01-11
Completion date
2027-04-05
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative, Opioid Use, Perioperative Complication, Heart Diseases

Keywords

plane block, sternotomy, thoracotomy, cardiac, surgery, postoperative, pain, anesthesia, opioid, pragmatic trial

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 hydrochloride) for pain management and outcomes after cardiac surgeries.

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 Recovery After Surgery (ERAS), reducing postoperative pain not only increases patient satisfaction, but also decreases postoperative complications and improves outcomes. Reduced postoperative pain also decreases rates of pneumonia and time on mechanical ventilation, in the ICU, or in the hospital. Importantly, decreasing postoperative pain can also reduce high dose opioid usage, the established method of managing postoperative pain, thereby decreasing rates of nausea/vomiting, intubation time, and mortality. Methods of reducing postoperative pain, such as neuraxial anesthesia and deep plexus blocks, are associated with an increased risk of epidural hematoma; an alternate solution, therefore, is using fascial plane blocks. Since 2018, our institution is one of very few that uses pre-operative fascial plane blocks for cardiac surgery patients, implementing bilateral plane blocks for the sternotomy approach and unilateral plane blocks for the right mini-thoracotomy approach. Results from these blocks have been quite favorable but not yet validated. A study in which subjects are randomized to not receive an ESP block preoperatively would raise concerns regarding equipoise. Therefore, this study is designed to better understand the overall effects of these blocks by comparing FDA approved medications, Exparel (current practice at RWJUH) and Marcaine. Marcaine (0.25% bupivacaine HCl) has an onset of action on the order of seconds and generally within one minute from the time of injection, and an effect duration of roughly seven hours. Exparel is a commercially available extended-release formulation of liposomal bupivacaine, which extends the effect duration to an upward of 72 hours from the time of injection with similarly immediate onset of action. Several studies have compared local injections of Marcaine (plain bupivacaine) with Exparel (liposomal bupivacaine) in the setting of inguinal hernia repair, knee arthroplasty, breast augmentation, and hemorrhoidectomy, with results favoring the use of liposomal bupivacaine based on improvements in subjective pain at the initial postoperative pain assessment.(6) Clinical trials are currently underway, investigating the effect of liposomal bupivacaine for local anesthesia and compared with epidural anesthesia in thoracoscopic surgery. In a recent clinical trial published in the Journal of the American Medical Association (JAMA), patients undergoing cardiothoracic or vascular surgery subjected to truncal incisions did not demonstrate a significant benefit with respect to pain control or adjunctive opioid usage when treated with liposomal bupivacaine over plain bupivacaine via local injection. Still, a gap in the literature exists with respect to the use of liposomal bupivacaine versus plain bupivacaine for erector spinae plane block in the setting of sternotomy. The aim of this prospective study is to determine the impact of preoperative fascial plane blocks with Exparel compared to Marcaine on outcomes following cardiac procedures.

Interventions

Bupivacaine liposome injectable suspension (Exparel) will be administered by ultrasound-guided ESP block, unilaterally if thoracotomy on ipsilateral side, bilaterally if median sternotomy.

DRUGBupivacaine Hydrochloride

Bupivacaine HCl (Marcaine) will be administered by ultrasound-guided ESP block, unilaterally if thoracotomy on ipsilateral side, bilaterally if median sternotomy.

Sponsors

Rutgers, The State University of New Jersey
Lead SponsorOTHER
Pacira Pharmaceuticals, Inc
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative opioid consumptionPostoperative days 0 through 5Postoperative opioid consumption within first five postoperative days, reported as average mg/day in morphine equivalents.

Secondary

MeasureTime frameDescription
Postoperative nonopioid analgesic consumptionPostoperative days 0 through 5Postoperative non-opioid analgesic (Pregabalin, Gabapentin, selective serotonin reuptake inhibitor (SSRI), selective norepinephrine reuptake inhibitor (SNRI), Ketorolac, Tramadol, Ibuprofen, and Acetaminophen) consumption within first five postoperative days, reported as average mg/day.
Inpatient postoperative pain scorePostoperative days 0 through 5Pain scores through postoperative day five, using the standard Numeric Rating Scale (NRS), wherein a score of 0 corresponds to "no pain," 5 to "moderate pain," and 10 to "worst possible pain," reported as mean score over all five days.
Outpatient postoperative pain scoreObtained within 30 days following surgerySingle pain score at follow-up visit, using the standard Numeric Rating Scale (NRS), wherein a score of 0 corresponds to "no pain," 5 to "moderate pain," and 10 to "worst possible pain."
30-day mortality rateThrough postoperative day 30Proportion of patients who expire within 30 postoperative days from the index operation.
30-day major morbidity rateThrough postoperative day 30Proportion of patients who experience the composite outcome of major morbidity, defined as the occurrence of any of the following within 30 postoperative days from the index operation: pneumonia, respiratory failure with ventilatory support \>48h, pulmonary embolism (PE), deep vein thrombosis (DVT), multi-organ dysfunction syndrome, postoperative myocardial infarction (MI), acute renal failure requiring renal replacement therapy, cerebrovascular accident (CVA), infection of wound or line or urinary tract infection (UTI), readmission, sustained postoperative atrial or ventricular arrhythmia, new postoperative atrial fibrillation, exacerbation of pre-existing atrial fibrillation
Postoperative qualify of lifeWithin the range of 30 days prior to surgery to 30 days after surgeryMeasured as change on the 12-item Short Form Survey (SF-12) from preoperative baseline to followup. Scores on the SF-12 range from 0 to 100, with higher scores indicating better physical and mental health.
Hospitalization costStudy duration, limited to one year.Before-insurance cost of hospitalization and treatment.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLeonard Y Lee, MD

Rutgers Robert Wood Johnson Medical School, Dept of Surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026