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| Name | Class |
|---|---|
| Pacira Pharmaceuticals, Inc | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exparel | Experimental | The experimental medication (Exparel) will be administered per standard of care via ultrasound-guided erector spinae plane (ESP) blocks, bilaterally for sternotomy and unilaterally for mini-thoracotomy. The drug will be administered prior to cardiac surgery. The dosage will be determined by patient body weight. For this pilot project the investigators anticipate consenting 150 subjects to obtain 96 evaluable subjects; 48 Mini thoractomies (N=24 Exparel, N=24 Marcaine) 48 Open sternotomies (N=24 Exparel, N=24 Marcaine). |
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| Marcaine | Active Comparator | The active comparator medication (Marcaine) will be administered per standard of care via ultrasound-guided erector spinae plane (ESP) blocks, bilaterally for sternotomy and unilaterally for mini-thoracotomy. The drug will be administered prior to cardiac surgery. The dosage will be determined by patient body weight. For this pilot project the investigators anticipate consenting 150 subjects to obtain 96 evaluable subjects; 48 Mini thoracotomies (N=24 Exparel, N=24 Marcaine) 48 Open sternotomies (N=24 Exparel, N=24 Marcaine). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bupivacaine liposome injectable suspension | Drug | Bupivacaine liposome injectable suspension (Exparel) will be administered by ultrasound-guided ESP block, unilaterally if thoracotomy on ipsilateral side, bilaterally if median sternotomy. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative opioid consumption | Postoperative opioid consumption within first five postoperative days, reported as average mg/day in morphine equivalents. | Postoperative days 0 through 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative nonopioid analgesic consumption | Postoperative 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. | Postoperative days 0 through 5 |
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Inclusion Criteria:
Exclusion Criteria:
Patients will be excluded if they:
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| Name | Affiliation | Role |
|---|---|---|
| Leonard Y Lee, MD | Rutgers Robert Wood Johnson Medical School, Dept of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers RWJMS | New Brunswick | New Jersey | 08903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35274774 | Background | Toscano A, Barbero C, Capuano P, Costamagna A, Pocar M, Trompeo A, Pasero D, Rinaldi M, Brazzi L. Chronic postsurgical pain and quality of life after right minithoracotomy mitral valve operations. J Card Surg. 2022 Jun;37(6):1585-1590. doi: 10.1111/jocs.16400. Epub 2022 Mar 11. | |
| 30052229 | Background | Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18. |
| Label | URL |
|---|---|
| Exparel and Marcaine for Pain Management in Thoracoscopic Lobectomy Patients (BEMP) | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2025 | Jun 10, 2025 | Prot_SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 13, 2023 | Dec 28, 2023 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D006331 | Heart Diseases |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine Hydrochloride | Drug | Bupivacaine HCl (Marcaine) will be administered by ultrasound-guided ESP block, unilaterally if thoracotomy on ipsilateral side, bilaterally if median sternotomy. |
|
|
| Inpatient postoperative pain score | Pain 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. | Postoperative days 0 through 5 |
| Outpatient postoperative pain score | Single 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." | Obtained within 30 days following surgery |
| 30-day mortality rate | Proportion of patients who expire within 30 postoperative days from the index operation. | Through postoperative day 30 |
| 30-day major morbidity rate | Proportion 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 | Through postoperative day 30 |
| Postoperative qualify of life | Measured 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. | Within the range of 30 days prior to surgery to 30 days after surgery |
| Hospitalization cost | Before-insurance cost of hospitalization and treatment. | Study duration, limited to one year. |
| 30665850 | Background | Macaire P, Ho N, Nguyen T, Nguyen B, Vu V, Quach C, Roques V, Capdevila X. Ultrasound-Guided Continuous Thoracic Erector Spinae Plane Block Within an Enhanced Recovery Program Is Associated with Decreased Opioid Consumption and Improved Patient Postoperative Rehabilitation After Open Cardiac Surgery-A Patient-Matched, Controlled Before-and-After Study. J Cardiothorac Vasc Anesth. 2019 Jun;33(6):1659-1667. doi: 10.1053/j.jvca.2018.11.021. Epub 2018 Nov 19. |
| 33046362 | Background | Song K, Xu Q, Knott VH, Zhao CB, Clifford SP, Kong M, Slaughter MS, Huang Y, Huang J. Liposomal Bupivacaine-Based Erector Spinae Block for Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 May;35(5):1555-1559. doi: 10.1053/j.jvca.2020.09.115. Epub 2020 Sep 20. No abstract available. |
| 24431939 | Background | Collins JB, Song J, Mahabir RC. Onset and duration of intradermal mixtures of bupivacaine and lidocaine with epinephrine. Can J Plast Surg. 2013 Spring;21(1):51-3. doi: 10.1177/229255031302100112. |
| 27347237 | Background | Gadsden J, Long WJ. Time to Analgesia Onset and Pharmacokinetics After Separate and Combined Administration of Liposome Bupivacaine and Bupivacaine HCl: Considerations for Clinicians. Open Orthop J. 2016 Apr 12;10:94-104. doi: 10.2174/1874325001610010094. eCollection 2016. |
| 33724391 | Background | Sandhu HK, Miller CC 3rd, Tanaka A, Estrera AL, Charlton-Ouw KM. Effectiveness of Standard Local Anesthetic Bupivacaine and Liposomal Bupivacaine for Postoperative Pain Control in Patients Undergoing Truncal Incisions: A Randomized Clinical Trial. JAMA Netw Open. 2021 Mar 1;4(3):e210753. doi: 10.1001/jamanetworkopen.2021.0753. |
| 41923260 | Derived | Yoo J, Pepe RJ, Nithikasem S, Laraia KN, Yang NK, Lee LY. Liposomal bupivacaine versus bupivacaine hydrochloride erector spinae plane blocks in cardiac surgery: protocol for a pragmatic randomized controlled trial. Trials. 2026 Apr 2;27(1):270. doi: 10.1186/s13063-026-09620-8. |
| Study of Exparel Versus Epidural for Pain Control After Thoracotomy | View source |
| D012816 | Signs and Symptoms |
| D002318 | Cardiovascular Diseases |
| D000588 |
| Amines |