EXPAREL for Postoperative Pain
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Pacira Pharmaceuticals, Inc
Must not be taking: Opioids, Amide anesthetics
Disqualifiers: Coagulopathies, Immunodeficiency, Pre-term birth, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
This Phase 1, multicenter, open-label, randomized, bupivacaine-controlled study is designed to evaluate the pharmacokinetics (PK) and safety of EXPAREL vs. bupivacaine HCl for postsurgical analgesia in pediatric subjects aged 0 to less than 6 years of age undergoing cardiac surgery, utilizing local infiltration analgesia (LIA).
Will I have to stop taking my current medications?
The trial does not specify if participants must stop taking their current medications, but it does exclude those who have taken EXPAREL or bupivacaine HCl within 30 days before the study. It's best to discuss your current medications with the study team.
What data supports the effectiveness of the drug EXPAREL for postoperative pain?
Is EXPAREL (liposomal bupivacaine) generally safe for humans?
Research shows that EXPAREL, a form of bupivacaine, has been studied for safety in various uses. It has a favorable cardiac safety profile and similar tissue reaction to other bupivacaine solutions, with no detected nerve damage in studies. However, some inflammation and muscle damage were noted, so monitoring for local tissue injury is important.13567
What makes the drug EXPAREL unique for postoperative pain management?
Eligibility Criteria
This trial is for children aged 0 to less than 6 years undergoing cardiac surgery. Their guardians must understand the consent form and agree to follow the study's schedule. Children should be healthy enough for anesthesia (ASA Class 1-3). Different age groups will be studied in separate parts of the trial.Inclusion Criteria
Parent/guardian able to speak, read, and understand the language of the ICF and provide informed consent for the subject
American Society of Anesthesiologists (ASA) Class 1-3
Male or female subjects from 0 to less than 6 years of age on the day of surgery. For Part 1, the subject's age should be 2 years to less than 6 years. For Part 2, the subject's age should be 6 months to less than 2 years. For Part 3, the subject's age should be 0 to less than 6 months
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Exclusion Criteria
I have a history of blood clotting or immune system disorders.
History of pre-term birth (babies born before 37 weeks of pregnancy)
Clinically significant medical or psychiatric disease that, in the opinion of the investigator, indicates an increased vulnerability to study drugs and/or procedures
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Part 1 Treatment
Subjects aged 2 to less than 6 years receive a single dose of EXPAREL or bupivacaine HCl for PK and safety evaluation
1 week
1 visit (in-person)
Part 2 Treatment
Subjects aged 6 months to less than 2 years receive a single dose of EXPAREL or bupivacaine HCl for PK and safety evaluation
1 week
1 visit (in-person)
Part 3 Treatment
Subjects aged 0 to less than 6 months receive a single dose of EXPAREL or bupivacaine HCl for PK and safety evaluation
1 week
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
2 visits (in-person)
Treatment Details
Interventions
- bupivacaine (Local Anesthetic)
- EXPAREL (Local Anesthetic)
Trial OverviewThe study compares EXPAREL, a long-lasting pain reliever, with bupivacaine, a common local anesthetic, in young patients after heart surgery. It aims to see how these drugs are processed by the body and how safe they are when used for pain control.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: EXPARELExperimental Treatment1 Intervention
A total of approximately 24 subjects (8 subjects per Part) will be enrolled. Subjects in this arm will receive EXPAREL
Group II: bupivacaineActive Control1 Intervention
A total of approximately 24 subjects (8 subjects per Part) will be enrolled. Subjects in this arm will receive bupivacaine
EXPAREL is already approved in United States for the following indications:
🇺🇸 Approved in United States as Exparel for:
- Postsurgical local analgesia via infiltration in patients aged 6 years and older
- Postsurgical regional analgesia in adults via interscalene brachial plexus nerve block
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Oklahoma (OU) - Medical Center - The Children's HospitalOklahoma City, OK
The University of Texas Health Science Center at Houston (UTHSC-H) - McGovern Medical SchoolHouston, TX
Duke University Health SystemDurham, NC
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Who Is Running the Clinical Trial?
Pacira Pharmaceuticals, IncLead Sponsor
References
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.
Evaluation of DepoFoam(®) bupivacaine for the treatment of postsurgical pain. [2014]SUMMARY An extended-release, multivesicular liposome-encapsulated form of the local anesthetic bupivacaine, DepoFoam(®) bupivacaine (proposed proprietary name EXPAREL™), is in development for use as part of a multimodal regimen for the treatment of postsurgical pain. Placebo- and active-controlled clinical trials in patients who have undergone either orthopedic or soft-tissue procedures indicate that a single local administration into the surgical site results in analgesic activity for up to 3-4 days and decreases the use of opioid rescue medication. The safety profile of DepoFoam bupivacaine appears to be similar to that of bupivacaine HCl, and adverse events are dose-related.
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.
Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. [2022]Bupivacaine extended-release liposome injection is a novel formulation of bupivacaine designed to achieve long-acting postoperative analgesia.
Neurological and histological outcomes after subarachnoid injection of a liposomal bupivacaine suspension in pigs: a pilot study. [2019]An injectable liposomal bupivacaine suspension (EXPAREL™) is approved by the US Food and Drug Administration for analgesia by tissue infiltration and interscalene brachial plexus, but not for use in the neuraxial space. This pilot study describes neurological and histological outcomes of escalating doses of this extended-release formulation of bupivacaine after subarachnoid administration.
Bupivacaine extended-release liposome injection exhibits a favorable cardiac safety profile. [2019]Bupivacaine extended-release liposome injection is an investigational local analgesic intended for use in postsurgical pain management. In recognition of the incompletely characterized association of bupivacaine use and cardiac effects, this article reviews the cardiac safety profile of this novel formulation of bupivacaine.
Multivesicular liposomal bupivacaine at the sciatic nerve. [2022]Clinical translation of sustained release formulations for local anesthetics has been limited by adverse tissue reaction. Exparel™ (DepoFoam bupivacaine) is a new liposomal local anesthetic formulation whose biocompatibility near nerve tissue is not well characterized. Exparel™ injection caused sciatic nerve blockade in rats lasting 240 min compared to 120 min for 0.5% (w/v) bupivacaine HCl and 210 min for 1.31% (w/v) bupivacaine HCl (same bupivacaine content as Exparel™). On histologic sections four days after injection, median inflammation scores in the Exparel™ group (2.5 of 4) were slightly higher than in groups treated with bupivacaine solutions (score 2). Myotoxicity scores in the Exparel™ group (2.5 of 6) were similar to in the 0.5% (w/v) bupivacaine HCl group (3), but significantly less than in the 1.31% (w/v) bupivacaine HCl group (5). After two weeks, inflammation from Exparel™ (score 2 of 6) was greater than from 0.5% (w/v) bupivacaine HCl (1) and similar to that from 1.31% (w/v) bupivacaine HCl (1). Myotoxicity in all three groups was not statistically significantly different. No neurotoxicity was detected in any group. Tissue reaction to Exparel™ was similar to that of 0.5% (w/v) bupivacaine HCl. Surveillance for local tissue injury will be important during future clinical evaluation.
Local infiltration of liposome bupivacaine in orthopedic trauma patients: case-based reviews. [2022]Orthopedic trauma surgery is often associated with considerable postoperative pain, which can result in a cascade of direct and indirect clinical consequences. Patients undergoing orthopedic trauma surgery are at risk for the development of chronic postsurgical pain, which may persist for 2 years or longer. Effective approaches to reducing postoperative pain in orthopedic trauma surgery patients include the use of minimally invasive procedures and multimodal analgesia. Infiltration of the surgical site with EXPAREL® (bupivacaine liposome injectable suspension), an extended-release local anesthetic, represents an advance in the multimodal management of postoperative pain. As part of a multimodal regimen, EXPAREL® has been shown to provide effective, safe, and efficient analgesia across a range of surgical procedures. Two cases that illustrate the use of EXPAREL® in orthopedic trauma are described. The first case involves repair of a subtrochanteric nonunion in a 63-year-old woman with a history of bisphosphonate use and prior treatment with a cephalomedullary nail. The second case involves a young woman undergoing outpatient surgery for repair of a fractured clavicle. Both patients experienced good control of postsurgical pain, supporting the clinical utility of EXPAREL® in orthopedic trauma surgery.
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.