Pain Control with Exparel and Xylocaine for Rhinoplasty
Recruiting in Palo Alto (17 mi)
Overseen byMichael D Olson, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Mayo Clinic
Must not be taking: Anticoagulants
Disqualifiers: Pregnancy, Cardiac disease, Pulmonary disease, others
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
The purpose of this study is to find out whether injecting the U.S. Food and Drug Administration (FDA) approved drug EXPAREL®, a long acting (approximately 96 hours) numbing medication, will reduce pain after rib cartilage removal in comparison to the standard injection of XYLOCAINE®.
Will I have to stop taking my current medications?
The trial requires that you stop taking anticoagulation medications like aspirin, Coumadin, or Plavix during the study. If you are on these medications, you would need to discontinue them to participate.
What data supports the effectiveness of the drug Exparel for pain control in rhinoplasty?
Is the combination of Exparel and Xylocaine safe for use in humans?
Exparel (liposome bupivacaine) has been shown to be generally safe for use in humans for various surgical procedures, with some studies indicating mild inflammation and myotoxicity (muscle damage) similar to other bupivacaine formulations. No significant neurotoxicity (nerve damage) was detected in animal studies, suggesting it is safe for use near nerve tissues.13467
What makes the drug Exparel unique for pain control in rhinoplasty?
Exparel is unique because it is an extended-release local anesthetic that provides continuous pain relief for up to 72 hours after surgery, reducing the need for additional pain medications. This is achieved through its formulation as a liposome bupivacaine injectable suspension, which allows for a slow and sustained release of the anesthetic at the surgical site.23489
Eligibility Criteria
This trial is for individuals needing nasal surgery with rib cartilage removal who can consent to the study. It's not for nursing women, those with bleeding disorders or on blood thinners, heart or severe lung disease, kidney or liver issues, pregnant women, or anyone allergic to local anesthetics.Inclusion Criteria
I need nasal surgery for breathing problems or to improve my nose's appearance, involving cartilage grafting.
Willing and able to understand and provide written informed consent
Exclusion Criteria
Women who are currently nursing a child
I have a serious lung condition like severe asthma, COPD, or lung scarring.
I have a bleeding disorder like hemophilia or Von Willebrand disease.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either Exparel® or Xylocaine® injection during nasal surgery for pain control
1 day
1 visit (in-person)
Follow-up
Participants are monitored for pain scores and adverse reactions after treatment
7-10 days
1-2 visits (in-person or virtual)
Treatment Details
Interventions
- Exparel (Local Anesthetic)
- Xylocaine (Local Anesthetic)
Trial OverviewThe study aims to compare pain control after rib cartilage removal using EXPAREL®, a long-acting numbing medication lasting about 96 hours, against the standard XYLOCAINE® injection.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Exparel® Injection GroupExperimental Treatment1 Intervention
On the day of clinically indicated nasal surgery the surgical wound on the chest, where the rib cartilage is removed, will be injected with Exparel®
Group II: Xylocaine® Injection GroupActive Control1 Intervention
On the day of clinically indicated nasal surgery the surgical wound on the chest, where the rib cartilage is removed, will be injected with Xylocaine® as part of standard of care.
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 via an interscalene brachial plexus block in adults
- Postsurgical regional analgesia via a sciatic nerve block in the popliteal fossa in adults
- Postsurgical regional analgesia via an adductor canal block in adults
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
References
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.
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.
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.
Systematic Review of Liposomal Bupivacaine (Exparel) for Postoperative Analgesia. [2022]Management of postoperative pain often requires multimodal approaches. Suboptimal dosages of current therapies can leave patients experiencing periods of insufficient analgesia, often requiring rescue therapy. With absence of a validated and standardized approach to pain management, further refinement of treatment protocols and targeted therapeutics is needed. Liposomal bupivacaine (Exparel) is a longer acting form of traditional bupivacaine that delivers the drug by means of a multivesicular liposomal system. The effectiveness of liposomal bupivacaine has not been systematically analyzed relative to conventional treatments in plastic surgery.
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.
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.
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.
Local infiltration of liposome bupivacaine in foot and ankle surgery: case-based reviews. [2014]Foot and ankle surgical procedures, ranging from simple procedures, such as bunionectomy and correction of hammer toe, to more complex surgery, such as ankle fusion and ankle replacement, are extremely painful. Moreover, there is increasing interest in performing these procedures in an outpatient setting. Nerve blocks are extensively used in foot and ankle surgery, and commonly used techniques include sciatic nerve block with saphenous nerve augmentation; ankle block; and local, digital, or field block. Whereas more extensive blocks are associated with increased medical risk, higher cost, and delayed ambulation, more local approaches may not provide an adequate duration of effect. EXPAREL® (bupivacaine liposome injectable suspension) is an extended-release local anesthetic that can be infiltrated directly into the surgical site by the orthopedic surgeon to provide continuous and effective analgesia at the site of surgical injury for up to 72 hours. Two cases that illustrate the use of EXPAREL® in foot and ankle surgery are described. The first case involves ankle replacement in an active 58-year-old man with a 20-plus-year history of arthritis. The second case involves a young woman undergoing surgery for a talar neck fracture-dislocation with an open injury, dislocated subtalar joint, avascular talus, and considerable deformity. Both patients reported excellent control of postsurgical pain.