[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06077422":3,"trial-entities:NCT06077422":159,"trial-summary:NCT06077422":164},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":34,"primary_purpose":35,"phases":36,"enrollment_info":39,"interventions":42,"primary_outcomes":56,"secondary_outcomes":61,"sex":87,"minimum_age":88,"maximum_age":89,"healthy_volunteers":15,"eligibility_criteria":90,"std_ages":106,"locations":109,"central_contacts":119,"overall_officials":120,"references":125,"see_also_links":152},"NCT06077422","Pro2022001580","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","ENROLLING_BY_INVITATION","2027-04-05","2026-02","2026-02-17","2024-01-11","Rutgers, The State University of New Jersey","OTHER",false,"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.\n\nWith 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\u002Fvomiting, 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.\n\nSince 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.\n\nA 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.",[19,20,21,22],"Pain, Postoperative","Opioid Use","Perioperative Complication","Heart Diseases",[24,25,26,27,28,29,30,31,32,33],"plane block","sternotomy","thoracotomy","cardiac","surgery","postoperative","pain","anesthesia","opioid","pragmatic trial","INTERVENTIONAL","TREATMENT",[37,38],"PHASE2","PHASE3",{"count":40,"type":41},150,"ESTIMATED",[43,50],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":49},"DRUG","bupivacaine liposome injectable suspension","Bupivacaine liposome injectable suspension (Exparel) will be administered by ultrasound-guided ESP block, unilaterally if thoracotomy on ipsilateral side, bilaterally if median sternotomy.",[48],"Exparel",[48],{"type":44,"name":51,"description":52,"armGroupLabels":53,"otherNames":55},"Bupivacaine Hydrochloride","Bupivacaine HCl (Marcaine) will be administered by ultrasound-guided ESP block, unilaterally if thoracotomy on ipsilateral side, bilaterally if median sternotomy.",[54],"Marcaine",[54],[57],{"measure":58,"description":59,"timeFrame":60},"Postoperative opioid consumption","Postoperative opioid consumption within first five postoperative days, reported as average mg\u002Fday in morphine equivalents.","Postoperative days 0 through 5",[62,65,68,72,76,79,83],{"measure":63,"description":64,"timeFrame":60},"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\u002Fday.",{"measure":66,"description":67,"timeFrame":60},"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.",{"measure":69,"description":70,"timeFrame":71},"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",{"measure":73,"description":74,"timeFrame":75},"30-day mortality rate","Proportion of patients who expire within 30 postoperative days from the index operation.","Through postoperative day 30",{"measure":77,"description":78,"timeFrame":75},"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",{"measure":80,"description":81,"timeFrame":82},"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",{"measure":84,"description":85,"timeFrame":86},"Hospitalization cost","Before-insurance cost of hospitalization and treatment.","Study duration, limited to one year.","ALL","18 Years",null,{"inclusion":91,"exclusion":94,"raw_text":105},[92,93],"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).",[95,96,97,98,99,100,101,102,103,104],"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.","Inclusion Criteria:\n\n* Adults (18 years-no upper age limit)\n* Scheduled for mini thoracotomy (i.e. valve repair) or open sternotomy (i.e. bypass graft) at single academic medical center (in and out-patients).\n\nExclusion Criteria:\n\nPatients will be excluded if they:\n\n* Are currently on pain medication or pain regimen for chronic pain condition\n* Convert to sternotomy (for thoracotomies)\n* Require, upon intraoperative discovery and surgeon's decision, the need for an unplanned secondary procedure other than the originally scheduled index operation\n* Undergo emergent surgery\n* 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.)\n* Mechanical circulatory support (MCS)\n* Vasoactive medications\n* Intubated\n* Active infection\n* Patients otherwise deemed ineligible for ESP block by the investigators due to safety concerns.",[107,108],"ADULT","OLDER_ADULT",[110],{"facility":111,"city":112,"state":113,"zip":114,"country":115,"geoPoint":116},"Rutgers RWJMS","New Brunswick","New Jersey","08903","United States",{"lat":117,"lon":118},40.48622,-74.45182,[],[121],{"name":122,"affiliation":123,"role":124},"Leonard Y Lee, MD","Rutgers Robert Wood Johnson Medical School, Dept of Surgery","PRINCIPAL_INVESTIGATOR",[126,130,133,136,139,142,145,148],{"pmid":127,"type":128,"citation":129},"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\u002Fjocs.16400. Epub 2022 Mar 11.",{"pmid":131,"type":128,"citation":132},"30052229","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\u002Faca.ACA_16_18.",{"pmid":134,"type":128,"citation":135},"30665850","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\u002Fj.jvca.2018.11.021. Epub 2018 Nov 19.",{"pmid":137,"type":128,"citation":138},"33046362","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\u002Fj.jvca.2020.09.115. Epub 2020 Sep 20. No abstract available.",{"pmid":140,"type":128,"citation":141},"24431939","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\u002F229255031302100112.",{"pmid":143,"type":128,"citation":144},"27347237","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\u002F1874325001610010094. eCollection 2016.",{"pmid":146,"type":128,"citation":147},"33724391","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\u002Fjamanetworkopen.2021.0753.",{"pmid":149,"type":150,"citation":151},"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\u002Fs13063-026-09620-8.",[153,156],{"label":154,"url":155},"Exparel and Marcaine for Pain Management in Thoracoscopic Lobectomy Patients (BEMP)","https:\u002F\u002Fclassic.clinicaltrials.gov\u002Fct2\u002Fshow\u002FNCT03682224",{"label":157,"url":158},"Study of Exparel Versus Epidural for Pain Control After Thoracotomy","https:\u002F\u002Fclinicaltrials.gov\u002Fct2\u002Fshow\u002FNCT02178553",{"nct_id":4,"conditions":160,"biomarkers":163},[161,162],"Heart Disorder","Post-Operative Pain",[],{"nct_id":4,"found":15,"summary":89,"prompt_version":89}]