Exparel Injection for Postoperative Pain
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Mayo Clinic
Disqualifiers: Under 18, Pregnant, Nursing
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?After surgery to remove the eye, either by enucleation or evisceration, patients have variable levels of pain for several postoperative days. Some patients have almost no discomfort while others require significant amounts of oral narcotics and report pain of 10 out of 10 on a numerical rating scale. The current operative standard is to infiltrate the eye socket with 0.5% bupivacaine during surgery leading to several hours of postoperative analgesia. In 2011, Pacira Pharmaceuticals released a bupivacaine liposomal injectable suspension (Exparel, 1.3%) which offers sustained release of bupivacaine giving postoperative pain control for up to 72 hours. This medication has been used in numerous surgeries including inguinal hernia repair, hemorrhoidectomy, bunionectomy, breast reconstruction, and orthopedic surgery, and the literature reports improved pain control, decreased use of oral opioids, and increased patient satisfaction. There are no reports of the use of Exparel in the ophthalmic literature. The investigators propose a randomized, controlled trial to compare the postoperative pain control offered by sustained release bupivacaine to that offered by standard plain bupivacaine after enucleation or evisceration.
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 Exparel Injection for postoperative pain?
Research shows that Exparel, a form of bupivacaine, can significantly reduce postoperative pain and the need for opioids in various surgeries, such as knee and hip replacements. Studies also indicate that it provides extended pain relief for up to several days after surgery.
12345Is Exparel Injection safe for humans?
Exparel, a form of bupivacaine, has been shown to be generally safe in humans when used as directed. Studies indicate minimal side effects when used for pain relief in surgeries, and it is approved by the FDA for surgical infiltration anesthesia.
13567How is the drug Exparel different from other treatments for postoperative pain?
Exparel is unique because it is a liposomal bupivacaine, which means it is a slow-release form of the local anesthetic bupivacaine, allowing for extended pain relief with a single injection at the surgical site. This can reduce the need for opioids and provide longer-lasting pain control compared to traditional bupivacaine formulations.
23489Eligibility Criteria
This trial is for adult patients at Mayo Clinic Rochester undergoing eye removal surgery (enucleation or evisceration) who can understand and use a numerical rating scale to report pain, nausea, and satisfaction. It's not for those under 18 years old or pregnant/nursing individuals.Inclusion Criteria
I am having my eye removed at Mayo Clinic Rochester by the Ophthalmology Department.
Willing and able to comprehend a numerical rating scale system and provide a score to assess pain, nausea, and satisfaction level.
Exclusion Criteria
I am 18 years old or older.
I am not pregnant or nursing.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Intraoperative injection of local anesthetic agent, either standard plain bupivacaine or sustained release bupivacaine (Exparel)
Immediate postoperative period
1 visit (in-person, during surgery)
Postoperative Monitoring
Assessment of postoperative pain, nausea, vomiting, and patient satisfaction on day 3 post-surgery
3 days
1 visit (in-person or virtual)
Follow-up
Participants are monitored for postoperative complications and overall recovery
6-8 weeks
1 visit (in-person)
Participant Groups
The study tests if Exparel, a long-lasting bupivacaine suspension providing up to 72 hours of pain control, is more effective than the standard bupivacaine used during eye socket surgeries in reducing postoperative pain.
2Treatment groups
Experimental Treatment
Active Control
Group I: Exparel (sustained release bupivacaine)Experimental Treatment1 Intervention
Intraoperative injection of local anesthetic agent, long acting agent
Group II: Plain bupivacaineActive Control1 Intervention
Intraoperative injection of local anesthetic agent, standard of care
Bupivacaine is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Marcaine for:
- Local anesthesia for surgery
- Acute pain management
- Spinal anesthesia
🇪🇺 Approved in European Union as Marcaine for:
- Local anesthesia for surgery
- Acute pain management
- Spinal anesthesia
🇨🇦 Approved in Canada as Sensorcaine for:
- Local anesthesia for surgery
- Acute pain management
- Spinal anesthesia
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
Intraoperative Sensorcaine significantly improves postoperative pain management in outpatient reduction mammaplasty. [2021]Breast reduction is one of the most frequently performed plastic surgical procedures in the United States; more than 160,500 patients underwent the procedure in 2005. Many outpatient reduction mammaplasty patients report the greatest postoperative discomfort in the first 48 hours. The authors' investigated the effect of intraoperative topical application of the long-acting local anesthetic agent bupivacaine (Sensorcaine or Marcaine) on postoperative pain, time to postanesthesia care unit discharge, and postoperative use of narcotic medication.
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.
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.
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.
[The use of Marcaine in obstetrical analgesia]. [2013]Bupivacaine (Marcaine) is being used increasingly in obstetrics for epidural analgesia, by virtue of the good sensory block obtained and the minimum of side-effects on the mother and newborn infant. At a concentration of less than 0.5 p. 100, analgesia is excellent with a minimal effect on motor fibres. Side-effects and toxicity are limited by the use of fractionated doses from the beginning of labour or of a single dose during or at the end of labour calculated in relation to the effect sought. Any action on the newborn infant would appear to be exceptional, if dose recommendations are respected, the high percentage of Marcaine bound to proteins limiting its transplacental passage.
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.
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.
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.
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.