ZYNRELEF for Pain Management
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method for managing pain in patients undergoing shoulder replacement surgery. One group will receive ZYNRELEF, a topical medication applied during the operation, while the other group will use a traditional pain management method involving a nerve block with a catheter. The researchers aim to determine if ZYNRELEF can reduce the need for opioids after surgery. Suitable candidates are adults planning their first total shoulder replacement and not currently using narcotics. Participants will report on their pain and medication use post-surgery. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved and effective ZYNRELEF can benefit more patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude people who are currently using narcotics or have used them consistently in the last 6 months, as well as those using oral steroids around the time of surgery.
What is the safety track record for these treatments?
Research has shown that Zynrelef, a medication for pain relief, has been tested for safety in many patients. Specifically, its safety was evaluated in 1,627 patients across 14 clinical studies. These studies involved various surgeries and found that Zynrelef is generally safe to use. One study found that using Zynrelef with a nerve block is also safe.
Zynrelef combines a local anesthetic, which numbs a specific area of the body, with an anti-inflammatory drug to manage pain and reduce swelling. This combination aims to provide better pain relief than traditional methods. While individual experiences may vary, evidence suggests that most people tolerate Zynrelef well.12345Why are researchers enthusiastic about this study treatment?
Zynrelef is unique because it combines bupivacaine, a long-acting local anesthetic, with meloxicam, a nonsteroidal anti-inflammatory drug (NSAID), in a single-dose application. This innovative combination offers extended pain relief for up to 72 hours after surgery, reducing the need for opioids. Unlike traditional pain management options like single-agent local anesthetics or systemic NSAIDs, Zynrelef delivers both immediate and sustained pain relief directly at the surgical site, potentially improving patient comfort and recovery time. Researchers are excited about its potential to minimize opioid use and enhance post-surgical pain management.
What evidence suggests that ZYNRELEF is effective for pain management in shoulder replacement surgery?
Research has shown that ZYNRELEF, one of the treatments in this trial, effectively manages pain after surgery for up to 72 hours. Studies found that patients using ZYNRELEF experienced less pain and required fewer opioid painkillers compared to those using only bupivacaine. In this trial, participants will receive either ZYNRELEF or an interscalene block with a continuous catheter pump. Pain relief with ZYNRELEF was 25% to 70% better than with bupivacaine or a placebo. This reduction in pain can decrease the need for strong painkillers after surgery, which is important for recovery.12678
Who Is on the Research Team?
Alexander Aleem, MD
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
This trial is for individuals undergoing total shoulder replacement who need pain management. Participants must be able to report their pain levels and narcotic use after surgery. Specific inclusion and exclusion criteria are not listed, but typically involve factors like age, general health status, and absence of conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Local intra-operative application of ZYNRELEF or interscalene block with catheter during shoulder replacement surgery
Follow-up
Participants are monitored for narcotic consumption, pain scores, and pain satisfaction after surgery
What Are the Treatments Tested in This Trial?
Interventions
- Bupivacaine
- Zynrelef
Trial Overview
The study compares ZYNRELEF (a topical medication) applied during surgery to an interscalene block with catheter for post-surgery pain control. It measures which method leads to less opioid use after surgery. Patients' experiences with pain and satisfaction will also be tracked without blinding.
How Is the Trial Designed?
2
Treatment groups
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
Citations
72 Hours of Postoperative Pain Relief | ZYNRELEF
ZYNRELEF patients experienced superior pain relief through 72 hours compared to patients receiving bupivacaine HCl solution.
Safety and Efficacy of Zynrelef® in Combination with a Single ...
This study provides evidence that the combination of a single unilateral or bilateral nerve block with Zynrelef is safe.
ZYNRELEF | Information for Pharmacists
The synergistic formulation of ZYNRELEF demonstrates a strong PK/PD relationship and provides 72 hours of pain relief and reduced opioid use after surgery.
4.
ir.herontx.com
ir.herontx.com/news-releases/news-release-details/heron-therapeutics-announces-publication-showing-zynrelefrNews Release Details
ZYNRELEF demonstrated superior, sustained postoperative pain relief for up to 72 hours and decreased the need for opioids, with more patients opioid-free ...
5.
anesthesiologynews.com
anesthesiologynews.com/Pain-Medicine/Article/11-21/Bupivacaine-Meloxicam-Combination-Provides-Better-Opioid%E2%80%93Sparing-Pain-Control-Than-Bupivacaine-HCl-Alone/65143?ses=ogstBupivacaine-Meloxicam Combo Opioid–Sparing Pain ...
“The decrease in pain in the Zynrelef group was between 25% and 70% compared to either bupivacaine or placebo,” Oderda said. In addition, the ...
211988Orig1s013 | FDA
The safety of ZYNRELEF has been evaluated in a total of 1627 patients undergoing various surgical procedures across 14 clinical studies ...
Pain Management in Orthopedic Surgery
When treated with ZYNRELEF plus a non-opioid MMA regimen, the majority of patients rated their pain control as “good” or “excellent”: 88% on day 1 of recovery, ...
A Foundation for Postoperative Pain Management
ZYRELEF combines local anesthetic bupivacaine with low-dose NSAID meloxicam to overcome challenges of inflammation at the surgical site.
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