Exparel vs. Marcaine ESP Block for Post-cardiac Surgical Pain
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Phase 2/Phase 3 |
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.
It would be unethical to do a study in which subjects are randomized to not receive the block preoperatively. 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 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Exparel 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 we anticipate consenting 120 subjects to obtain 96 evaluable subjects; 48 Mini thoractomies (N=24 Exparel, N=24 Marcaine) 48Open sternotomies (N=24 Exparel, N=24 Marcaine). |
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.
Other Names:
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| Active Comparator: Marcaine The active comparitor 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 we anticipate consenting 120 subjects to obtain 96 evaluable subjects; 48 Mini thoractomies (N=24 Exparel, N=24 Marcaine) 48Open sternotomies (N=24 Exparel, N=24 Marcaine). |
Drug: Bupivacaine Hydrochloride
Bupivacaine HCl (Marcaine) will be administered by ultrasound-guided ESP block, unilaterally if thoracotomy on ipsilateral side, bilaterally if median sternotomy.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Postoperative opioid consumption [Postoperative days 0 through 5]
Postoperative opioid consumption within first five postoperative days, reported as average mg/day in morphine equivalents.
- Postoperative nonopioid analgesic consumption [Postoperative days 0 through 5]
Postoperative nonopioid analgesic (Pregabalin, Gabapentin, SSRI/SNRI, Ketorolac, Tramadol, Ibuprofin, and Acetaminophen) consumption within first five postoperative days, reported as average mg/day in morphine equivalents.
Secondary Outcome Measures
- Inpatient postoperative pain score [Postoperative days 0 through 5]
Pain scores through postoperative day five, reported as mean score (1-10, 10 most severe) over all five days.
- Outpatient postoperative pain score [Obtained within 30 days following surgery]
Single pain score at follow-up visit
- 30-day outcomes [Through postoperative day 30]
Postoperative complications and outcomes (composite of all-cause mortality and major morbidity): Pneumonia, Respiratory failure with ventilatory support >48h, Pulmonary embolism, DVT, Organ Failure, Postop MI, Renal replacement therapy, Infection of wound or line, Readmission, Postoperative Arrhythmia, Postoperative atrial fibrillation, death
- Postoperative qualify of life [Within the range of 30 days prior to surgery to 30 days after surgery]
Measured as change on SF-12 survey from preoperative baseline to followup.
- Hospitalization cost [Study duration, limited to one year.]
Before-insurance cost of hospitalization and treatment.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults (18 years-no upper age limit)
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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:
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Are currently on pain medication or pain regimen
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Convert to open heart procedure (for thoracotomies)
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Require additional procedure then originally scheduled
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Undergo emergent surgery
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Are non-English speaking (The majority of the PI's patient population speak English. As a pilot study we cannot afford the time, effort or money to enroll non-English speaking subjects.)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Rutgers, The State University of New Jersey
- Pacira Pharmaceuticals, Inc
Investigators
- Principal Investigator: Leonard Y Lee, MD, Rutgers Robert Wood Johnson Medical School, Dept of Surgery
Study Documents (Full-Text)
More Information
Additional Information:
- Exparel and Marcaine for Pain Management in Thoracoscopic Lobectomy Patients (BEMP)
- Study of Exparel Versus Epidural for Pain Control After Thoracotomy
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Pro2022001580