Liposomal Bupivacaine vs. Bupivacaine for Wrist Fractures
(Vs Trial)
Recruiting in Palo Alto (17 mi)
Overseen byJay Schoenherr, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: University of North Carolina, Chapel Hill
Disqualifiers: Peripheral neuropathy, Neurological disorder, Pregnancy, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?Orthopedic wrist procedures often cause significant postoperative pain. A supraclavicular nerve block is an effective and proven method to help reduce postoperative pain and decrease opioid use around the time of upper extremity surgery. Liposomal bupivacaine (Exparel) has been approved for use around the brachial plexus, but its analgesic efficacy has limited data. The investigators' goal is to evaluate the effectiveness of Exparel as compared to plain bupivacaine. The investigators hope to ensure the quality of pain control around the time of distal radius fracture repair and reduce the variability of care at the investigators institution by prospectively and rigorously collecting perioperative data during this study.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug liposomal bupivacaine for wrist fractures?
Some studies suggest that liposomal bupivacaine may help control pain after wrist operations, but overall evidence shows it is not consistently more effective than standard bupivacaine. In many cases, traditional bupivacaine provides better pain relief, especially when used in a nerve block.
12345Is liposomal bupivacaine safe for use in humans?
Liposomal bupivacaine has been approved by the FDA for certain types of pain relief and has been shown to be safe in various surgeries, such as breast augmentation. However, it is not approved for use in the neuraxial space (around the spinal cord).
24678How does liposomal bupivacaine differ from regular bupivacaine for wrist fractures?
Liposomal bupivacaine is a unique formulation that uses tiny fat-like particles to slowly release the drug over time, potentially providing longer-lasting pain relief compared to regular bupivacaine, which is released more quickly and may require more frequent dosing.
910111213Eligibility Criteria
This trial is for individuals undergoing surgery to repair a distal radius fracture, commonly known as a broken wrist. Participants should be suitable for receiving nerve blocks for pain management post-surgery.Inclusion Criteria
I am scheduled for wrist fracture repair at UNC Chapel Hill.
I am 18 years old or older.
Exclusion Criteria
Pregnancy Pregnant women have physiologic changes that make them more sensitive to local anesthetics. That would introduce a confounding element in interpreting the effectiveness of the peripheral nerve blocks being studied.
I cannot have regional anesthesia due to health reasons.
I have severe nerve damage or a nerve disorder affecting my arms.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Pre-operative
Participants receive a preoperative supraclavicular nerve block with either plain bupivacaine or liposomal bupivacaine
1 day
1 visit (in-person)
Post-operative
Participants are monitored for pain management and opioid consumption, with assessments up to 48 hours post-surgery
2 days
Follow-up via telephone
Follow-up
Participants are monitored for safety and effectiveness after treatment
1 week
Participant Groups
The study compares two types of medication used in supraclavicular nerve blocks: traditional Bupivacaine Hydrochloride and Liposomal bupivacaine (Exparel). The goal is to see which one provides better pain control after wrist fracture surgery.
2Treatment groups
Experimental Treatment
Active Control
Group I: Supraclavicular Liposomal Bupivacaine groupExperimental Treatment1 Intervention
This group will receive the liposomal bupivacaine
Group II: Supraclavicular Plain Bupivacaine groupActive Control1 Intervention
This group will receive the plain bupivacaine
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UNC Chapel HillChapel Hill, NC
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Who Is Running the Clinical Trial?
University of North Carolina, Chapel HillLead Sponsor
References
Bupivacaine Extended-Release Liposomal Injection Versus Bupivacaine HCl for Early Postoperative Pain Control Following Wrist Operations: A Prospective, Randomized Control Trial. [2021]This study evaluated pain control after wrist operations using a long-acting local anesthetic, liposomal bupivacaine, compared with the standard local anesthetic, bupivacaine HCl.
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).
Liposomal Bupivacaine Does Not Reduce Inpatient Opioid Prescription or Related Complications after Knee Arthroplasty: A Database Analysis. [2019]WHAT THIS MANUSCRIPT TELLS US THAT IS NEW: BACKGROUND:: Although some trials suggest benefits of liposomal bupivacaine, data on real-world use and effectiveness is lacking. This study analyzed the impact of liposomal bupivacaine use (regardless of administration route) on inpatient opioid prescription, resource utilization, and opioid-related complications among patients undergoing total knee arthroplasties with a peripheral nerve block. It was hypothesized that liposomal bupivacaine has limited clinical influence on the studied outcomes.
Clinical Effectiveness of Liposomal Bupivacaine Administered by Infiltration or Peripheral Nerve Block to Treat Postoperative Pain. [2021]The authors provide a comprehensive summary of all randomized, controlled trials (n = 76) involving the clinical administration of liposomal bupivacaine (Exparel; Pacira Pharmaceuticals, USA) to control postoperative pain that are currently published. When infiltrated surgically and compared with unencapsulated bupivacaine or ropivacaine, only 11% of trials (4 of 36) reported a clinically relevant and statistically significant improvement in the primary outcome favoring liposomal bupivacaine. Ninety-two percent of trials (11 of 12) suggested a peripheral nerve block with unencapsulated bupivacaine provides superior analgesia to infiltrated liposomal bupivacaine. Results were mixed for the 16 trials comparing liposomal and unencapsulated bupivacaine, both within peripheral nerve blocks. Overall, of the trials deemed at high risk for bias, 84% (16 of 19) reported statistically significant differences for their primary outcome measure(s) compared with only 14% (4 of 28) of those with a low risk of bias. The preponderance of evidence fails to support the routine use of liposomal bupivacaine over standard local anesthetics.
Liposomal bupivacaine versus continuous infusion bupivacaine via an elastomeric pump for the treatment of postoperative pain. [2019]The duration of analgesia and comparative efficacy of liposomal bupivacaine and an elastomeric bupivacaine pump in a diverse surgical population were determined.
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.
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.
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.
[Lipid formulations of amphotericin B in the management of invasive fungal infections]. [2019]Three lipid formulations of amphotericin B have been developed: amphotericin B colloidal dispersion, amphotericin B lipid complex, and liposomal amphotericin B. These three compounds differ by their lipid composition and therefore by their physical characteristics, their pharmacokinetics, and their safety and efficacy profile. There is a consensus to accept reduced toxicity of these formulations, especially reduced, but not absence of, renal toxicity as compared to amphotericin B deoxycholate. Few well-designed studies have been conducted and none of them demonstrated convincingly superiority in term of efficacy of any of the lipid preparations over amphotericin B deoxycholate. Recently a double blind randomized study compared a standard dose of 3 mg/kg/d of liposomal amphotericin B and a loading dose (10 mg/kg/d for 14 days and then the standard dose) in primary therapy of invasive filamentous fungal infections, mainly aspergillosis. Response rate at end of randomized therapy as well as survival at 12 weeks was numerically superior in the standard dose arm but this difference was not statistically significant. Lack of benefit of high dose liposomal amphotericin B in aspergillosis cannot yet be extrapolated to other filamentous fungal infections. Nephrotoxicity was substantially higher in the loading dose arm and this contraindicates its use in clinical practice.
Activity of a new liposomal formulation of amphotericin B against two strains of Leishmania infantum in a murine model. [2020]The efficacy of a new liposomal formulation of amphotericin B was compared to that of amphotericin B deoxycholate (Fungizone) in a murine model of visceral leishmaniasis induced by Leishmania infantum. Median effective doses (ED50) were determined with two different strains: strain 1 was obtained from an untreated patient, and strain 2 was obtained from a patient who had received 12.5 g of amphotericin B over 3 years. BALB/c mice were infected intravenously on day 0 with promastigotes and then treated on days 14, 16, and 18 (strain 1) or on days 21, 23, and 25 (strain 2) with the liposomal formulation of amphotericin B (five doses were tested for each strain: 0.05, 0.1, 0.5, 0.8, and 3 mg/kg of body weight) or with conventional amphotericin B (four doses were tested for each strain: 0.05, 0.1, 0.5, and 0.8 mg/kg). Mice in the control group received normal saline solution. The liposomal amphotericin B formulation was about three times more active than the conventional drug against both strains. ED50 of the liposomal formulation were 0.054 (strain 1) and 0.194 (strain 2) mg/kg. ED50 of conventional amphotericin B were 0.171 (strain 1) and 0.406 (strain 2) mg/kg. Determination of drug tissular levels, 3 days after the last drug administration, showed a drug accumulation in hepatic and splenic tissues much higher after administration of liposomal amphotericin B than after conventional amphotericin B. A lack of toxicity was noted in all groups treated with the liposomal formulation.
Liposomal amphotericin B versus pentavalent antimony salts for visceral Leishmania in children. [2013]The aim of this study was to investigate the efficacy of a 21-day schedule of liposomal amphotericin B compared to pentavalent antimony salts in the treatment of patients during a first episode of visceral leishmaniasis. In this study, 17 cases of visceral leishmaniasis admitted to Behçet Uz Children's Hospital between January 2005 and April 2012 were reviewed retrospectively. The study group was composed of 11 males (64.7%) and 6 females (35.3%). One group included 11 patients who were treated with pentavalent antimony salts, sodium stibogluconate or meglumine antimoniate, intramuscularly for 28 days. The second group was treated with amphotericin B intravenously at a dosage of 3 mg/kg on days 1-5, 10 and 21 (a cumulative dose of 21 mg/kg/day). While pentavalent antimony salts were found to increase biochemical and hematological findings, liposomal amphotericin B was responsible for rapid recovery in fever and shorter hospital stay. As a result, our study shows the advantages of both medications independent of their costs.
Liposomal amphotericin B: clinical experience and perspectives. [2013]While amphotericin B deoxycholate (Fungizone, Apothecon Pharmaceuticals) has been considered by many to be the gold standard for the treatment for numerous invasive fungal infections for over 45 years, toxicities associated with its use often necessitate treatment modification or discontinuation. Lipid-based formulations, including liposomal amphotericin B (AmBisome, Fujisawa Healthcare, Inc.), were developed to decrease many of these toxicities while retaining broad antifungal spectrum and potency of amphotericin B. In clinical trials, liposomal amphotericin B has demonstrated efficacy comparable to that of amphotericin B deoxycholate while reducing the incidence of treatment-related nephrotoxicity, electrolyte-wasting, and infusion-related reactions. In addition, recent clinical trials have also compared liposomal amphotericin B with other antifungal classes. Acquisition costs of liposomal amphotericin B are substantially higher than those of amphotericin B deoxycholate and other antifungals. While pharmacoeconomic analyses consider outcomes and other treatment-related costs, they have yet to clearly demonstrate the cost-effectiveness of liposomal amphotericin B when compared with amphotericin B deoxycholate or other antifungal agents. This review will focus primarily on recent liposomal amphotericin B experience and attempt to put its use into perspective considering other available antifungal agents.
Single-dose liposomal amphotericin B for visceral leishmaniasis in India. [2022]Some 50% of patients with visceral leishmaniasis (kala-azar) worldwide live in the Indian state of Bihar. Liposomal amphotericin B is an effective treatment when administered in short courses. We wanted to determine whether the efficacy of a single infusion of liposomal amphotericin B was inferior to conventional parenteral therapy, consisting of 15 alternate-day infusions of amphotericin B deoxycholate.