EXPAREL for Post-surgical Pain Relief
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two pain relief methods for individuals undergoing total ankle replacement surgery. It compares the effects of a single dose of EXPAREL, a long-lasting anesthetic, with 0.25% bupivacaine, a common painkiller. The study evaluates how well these drugs manage pain, reduce opioid use, and improve patient satisfaction. Participants should plan to have a single ankle replacement and not have other major pain conditions or certain medical issues. As a Phase 3 trial, this study serves as the final step before FDA approval, offering participants an opportunity to contribute to the development of potentially groundbreaking pain relief options.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, if you have a painful condition requiring regular pain medication or use opioids regularly, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found that EXPAREL, a long-lasting form of the pain reliever bupivacaine, was well-tolerated by patients. Common side effects included stomach pain, irritation at the injection site, and headaches, but these were not severe. The FDA has approved EXPAREL for pain relief after surgery, which supports its safety.
Research on 0.25% bupivacaine (HCl) has shown it is generally well-tolerated as well. It is used to numb areas during surgery and can cause heart-related side effects if administered in high doses. However, it is considered safe when used correctly.
Both treatments have undergone extensive testing in many studies, providing strong evidence of their safety for most patients. For those considering joining the trial, these findings suggest that both options are likely to be well-tolerated.12345Why are researchers excited about this trial's treatments?
Unlike the standard of care for post-surgical pain, which often relies on traditional anesthetics like bupivacaine alone, EXPAREL offers a unique approach by combining it with bupivacaine for extended relief. Researchers are excited about EXPAREL because it uses bupivacaine encapsulated in a lipid-based delivery system, allowing for a gradual release that can provide longer-lasting pain control. This means patients could potentially experience effective pain relief for a longer period after surgery, reducing the need for additional pain medication and improving overall recovery.
What evidence suggests that this trial's treatments could be effective for post-surgical pain relief?
Research has shown that EXPAREL, a special form of the pain reliever bupivacaine, effectively manages post-surgical pain. In this trial, participants will receive either EXPAREL combined with 0.25% bupivacaine HCl or bupivacaine HCl alone. Studies have found that patients receiving EXPAREL often report less pain and require fewer opioids for pain management after surgery. Specifically, one study noted that most patients using EXPAREL were satisfied with their pain relief 72 hours post-surgery. While traditional bupivacaine works well for some longer surgeries, it typically does not provide as much pain relief or reduce opioid use as effectively as EXPAREL. Overall, evidence suggests that EXPAREL may offer better pain control after surgery compared to regular bupivacaine.46789
Who Is on the Research Team?
Sameh Labib, MD, FAOA
Principal Investigator
Emory University
Are You a Good Fit for This Trial?
This trial is for individuals undergoing total ankle replacement who need post-surgical pain relief. Participants should not have anosognosia, a condition affecting self-awareness. Specific inclusion and exclusion criteria details are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose injection of EXPAREL or bupivacaine HCl for postsurgical analgesia
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pain intensity and opioid consumption
Long-term Follow-up
Participants' clinical performance and satisfaction are evaluated at 3 and 12 months post-surgery
What Are the Treatments Tested in This Trial?
Interventions
- 0.25% bupivacaine (HCl)
- EXPAREL
Trial Overview
The study compares the effectiveness of EXPAREL against traditional bupivacaine HCl in managing pain after ankle surgery. It measures how long the pain relief lasts, opioid use, time to first opioid dose, safety profiles, patient satisfaction with pain management, and recovery over 3 to 12 months.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Bupivacaine HCl arm Total volume (50 mL) will be split such that 30 mL will be administered as the sciatic nerve block (in the popliteal fossa) and 20 mL will be administered as the saphenous nerve block (in the adductor canal)
EXPAREL admixed with 0.25% bupivacaine HCl Total volume (50 mL) will be split such that 30 mL will be administered as the sciatic nerve block (in the popliteal fossa) and 20 mL will be administered as the saphenous nerve block (in the adductor canal)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
Pacira Pharmaceuticals, Inc
Industry Sponsor
Dr. Jonathan Slonin
Pacira Pharmaceuticals, Inc
Chief Medical Officer since 2020
BSc in Biomedical Engineering and MD from University of Miami, MBA from George Washington University
Frank D. Lee
Pacira Pharmaceuticals, Inc
Chief Executive Officer since 2024
BSc in Chemical Engineering from Vanderbilt University, MBA from Wharton Graduate School of Business
Citations
Effect of bupivacaine on postoperative pain and analgesics ...
Conclusion. Bupivacaine did not decrease pain and analgesics use. When surgery exceeded 40 minutes, bupivacaine use might be associated with less pain and less ...
Standard vs Liposomal Bupivacaine for Postoperative Pain ...
Liposomal bupivacaine did not provide improved pain control and did not reduce adjunctive opioid use compared with conventional bupivacaine formulation over 3 ...
NCT04362566 | Bupivacaine for Post-operative Pain in Mohs
In addition, a recent study has showed subcutaneous infiltration of bupivacaine with epinephrine to be an effective intra-operative pain adjuvant during MMS ...
72 Hours of Postoperative Pain Relief
ZYNRELEF patients experienced superior pain relief through 72 hours compared to patients receiving bupivacaine HCl solution.
Intradermal and Intramuscular Bupivacaine Reduces ...
Bupivacaine significantly reduced postoperative opioid consumption for 72 hours after surgery and slightly reduced pain ratings and conferred superior heart ...
Safety of liposome extended-release bupivacaine for ...
Results: Six studies fitted the inclusion criteria for analysis, DepoFoam bupivacaine used in therapeutic doses was well-tolerated, had a higher safety margin, ...
7.
mayoclinic.org
mayoclinic.org/drugs-supplements/bupivacaine-injection-route/description/drg-20406723Bupivacaine (injection route) - Side effects & uses
Bupivacaine injection is used to numb an area of your body during or after surgery or other procedures, childbirth, or dental work.
SABER®-Bupivacaine
over bupivacaine HCl for mean 72-hour pain reduction. • Data pooled from 5 trials with a bupivacaine HCl control arm indicated that SABER ...
Preclinical safety and feasibility of a bupivacaine-loaded ...
Preclinical safety and feasibility of a bupivacaine-loaded hydrogel for pain relief after spinal surgery.
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