Exparel vs. Marcaine for Postoperative Pain After Heart Surgery
Recruiting in Palo Alto (17 mi)
Overseen byLeonard Y Lee, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: Rutgers, The State University of New Jersey
Must not be taking: Pain medications
Disqualifiers: Non-English speaking, Active infection, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently on pain medication for a chronic pain condition.
What data supports the effectiveness of the drug Exparel for postoperative pain after heart surgery?
Research shows that Exparel, a slow-release form of bupivacaine, can extend pain relief for several days after surgery. In a study on cardiac surgery, Exparel was tested for its ability to control pain and reduce the need for opioids, although results were mixed.
12345Is Exparel (liposomal bupivacaine) safe for use in humans?
Exparel, a long-acting form of bupivacaine, has been shown to be safe in various surgeries, including breast augmentation and peripheral nerve blocks. It is approved for single-dose use to manage pain after surgery, and studies have generally supported its safety profile.
12456How does the drug Exparel differ from Marcaine for postoperative pain after heart surgery?
Exparel is a liposomal bupivacaine formulation that provides extended-release pain relief, potentially reducing the need for opioids after surgery. Unlike Marcaine, which is a standard bupivacaine hydrochloride, Exparel is designed for a single-dose application that can offer prolonged pain control.
13478Eligibility Criteria
This trial is for adults of any age who are scheduled for certain heart surgeries like valve repair or bypass graft at a specific academic medical center. It's not suitable for people outside this setting.Inclusion Criteria
I am 18 years old or older.
I am scheduled for a chest surgery at a specific academic medical center.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Preoperative
Administration of ultrasound-guided erector spinae plane (ESP) blocks using Exparel or Marcaine prior to cardiac surgery
Immediate pre-surgery
1 visit (in-person)
Postoperative Monitoring
Monitoring of postoperative opioid and non-opioid analgesic consumption, pain scores, and other outcomes
5 days
Daily monitoring (inpatient)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including outpatient pain scores and quality of life assessments
30 days
1 visit (in-person)
Participant Groups
The study compares two pain management drugs after heart surgery: Exparel (a long-acting form of bupivacaine) and Marcaine (a standard form), both administered via an ultrasound-guided Erector Spinae Plane Block.
2Treatment groups
Experimental Treatment
Active Control
Group I: ExparelExperimental Treatment1 Intervention
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 120 subjects to obtain 96 evaluable subjects; 48 Mini thoractomies (N=24 Exparel, N=24 Marcaine) 48 Open sternotomies (N=24 Exparel, N=24 Marcaine).
Group II: MarcaineActive Control1 Intervention
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 120 subjects to obtain 96 evaluable subjects; 48 Mini thoracotomies (N=24 Exparel, N=24 Marcaine) 48 Open sternotomies (N=24 Exparel, N=24 Marcaine).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Rutgers RWJMSNew Brunswick, NJ
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Who Is Running the Clinical Trial?
Rutgers, The State University of New JerseyLead Sponsor
Pacira Pharmaceuticals, IncIndustry Sponsor
References
A Prospective Randomized Study Comparing Bupivacaine Hydrochloride Versus Bupivacaine Liposome for Pain Management After Distal Radius Fracture Repair Surgery. [2018]To compare pain experience and opioid use after distal radius fracture repair surgery performed with perioperative infiltration of the local anesthesia bupivacaine hydrochloride (Marcaine; Pfizer, New York, NY) or bupivacaine liposome (Exparel; Pacira, Parsippany, NJ).
Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. [2020]Liposomal bupivacaine (Exparel®) is a sustained-release formulation of bupivacaine for use in surgical infiltration anaesthesia. We analysed the histological nerve toxicity and clinical effectiveness of perineural Exparel® alone or with added dexamethasone in a mouse model.
A Randomized Controlled Trial of Liposomal Bupivacaine Parasternal Intercostal Block for Sternotomy. [2019]Optimal pain control continues to be a concern in cardiac surgery. Current strategies for postoperative pain management often yield suboptimal results. The superiority of Exparel (Pacira Pharmaceuticals, Inc, Parsippany, NJ) in providing postoperative pain control and opioid sparing is equivocal. This prospective, randomized, double-blind study examines the efficacy of Exparel as a novel single-dose application parasternal nerve block in postoperative pain control and opioid sparing.
Does Liposomal Bupivacaine (Exparel) Significantly Reduce Postoperative Pain/Numbness in Symptomatic Teeth with a Diagnosis of Necrosis? A Prospective, Randomized, Double-blind Trial. [2017]Medical studies have shown some potential for infiltrations of liposomal bupivacaine (Exparel; Pacira Pharmaceuticals, San Diego, CA), a slow-release bupivacaine solution, to extend postoperative benefits of numbness/pain relief for up to several days. Because the Food and Drug Administration has approved Exparel only for infiltrations, we wanted to evaluate if it would be effective as an infiltration to control postoperative pain. The purpose of this study was to compare an infiltration of bupivacaine with liposomal bupivacaine for postoperative numbness and pain in symptomatic patients diagnosed with pulpal necrosis experiencing moderate to severe preoperative pain.
Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. [2022]Liposome bupivacaine (Exparel) is a multivesicular liposomal formulation of bupivacaine currently approved in the United States for single-dose administration into the surgical site to provide postsurgical analgesia. This retrospective analysis examined safety data from clinical trials involving the off-label use of this formulation in peripheral nerve blocks.
Bupivacaine Versus Liposomal Bupivacaine for Postoperative Pain Control after Augmentation Mammaplasty: A Prospective, Randomized, Double-Blind Trial. [2022]The long-acting preparation of bupivacaine, liposomal bupivacaine (EXPAREL, Pacira Pharmaceuticals, Inc., San Diego, CA), was approved by the Food and Drug Administration in October 2011 and has been shown to be safe in breast augmentation. It remains to be established if liposomal bupivacaine provides superior pain control in this setting.
Liposomal bupivacaine use in exploratory lingual nerve microsurgery: does liposomal bupivacaine use decrease postoperative pain and opioid consumption compared to bupivacaine hydrochloride? A pilot study. [2021]The purpose of this study was to determine if liposomal bupivacaine 1.3% (LB), Exparel (Pacira Pharmaceuticals), is more effective than bupivacaine hydrochloride 0.25% (BH), Marcaine (Hospira), in reducing postoperative pain and opioid consumption in patients undergoing exploratory lingual nerve microsurgery. The investigators hypothesized that patients who received LB would have a greater reduction in acute postoperative pain, and therefore, a reduction in total opioid use over 72 hours postoperatively.
Recent advances in incorporation of local analgesics in postsurgical pain pathways. [2014]Total knee and hip replacement surgeries are highly invasive, and a significant level of postoperative pain is commonplace in patients undergoing these procedures. It is now known that postoperative pain can affect hospital stay, patient satisfaction, postsurgical rehabilitation, and a range of other clinical and administrative outcomes. The need for a multimodal approach to the control of postoperative pain, using combinations of agents that have synergistic effects, is now widely accepted. There has been increasing interest in local periarticular and intra-articular injections, which can result in significantly less pain in the postanesthesiology care unit (PACU), significantly less use of rescue opioids in the PACU, significantly less confusion, significantly less blood loss, and a significantly lower bleeding index. EXPAREL® (bupivacaine liposome injectable suspension) is an extended-release anesthetic that is approved by the US Food and Drug Administration for single-dose injection into the surgical site to produce postsurgical analgesia. Several phase 2 and phase 3 studies across a range of surgical procedures have demonstrated that the inclusion of EXPAREL® in the multimodal regimen can significantly reduce both pain scores (including cumulative pain scores at 24 hours) and opioid consumption, as well as resulting in delayed time to the first use of opioids and more opioid-free patients at 72 hours. Multimodal regimens that include EXPAREL® may have important benefits in total joint arthroplasty.