Oliceridine for Major Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of oliceridine, a new medication for pain management after major surgery. Researchers aim to observe its side effects when used for patients requiring strong pain relief, equivalent to at least 20 mg of morphine. It suits those undergoing major surgeries lasting over two hours and necessitating a hospital stay of at least two nights. Individuals who cannot take oliceridine or regularly use strong painkillers are not eligible. As a Phase 4 trial, oliceridine has already received FDA approval and proven effective; this research seeks to understand its benefits for a broader range of 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 you cannot participate if you are expected to receive certain pain medications like gabapentin or pregabalin.
What is the safety track record for Oliceridine?
Research has shown that oliceridine is usually well-tolerated. Studies indicate it causes fewer side effects, such as nausea, compared to traditional opioids. However, about 23% of patients experienced some breathing issues, though none were life-threatening. This suggests that while oliceridine carries some risks, it might be safer in certain ways than other pain medications.12345
Why are researchers enthusiastic about this study treatment?
Oliceridine is unique because it provides pain relief with potentially fewer side effects compared to traditional opioids like morphine or fentanyl. Unlike these conventional opioids, Oliceridine selectively targets the mu-opioid receptor, which may reduce the risk of respiratory depression—a serious side effect associated with standard opioid use. Researchers are excited about Oliceridine as it promises effective pain management while potentially offering a safer profile, particularly for patients undergoing major surgery.
What is the effectiveness track record for Oliceridine in major surgery?
Research shows that oliceridine, which participants in this trial will receive, effectively manages sudden pain after surgery. Studies have found it works better than a placebo and is nearly as effective as morphine. Clinical data indicate that oliceridine is safe and generally well-tolerated, causing few unpleasant side effects. Additionally, its approval for treating severe pain confirms its effectiveness, making it a promising option for controlling pain after major surgery.36789
Who Is on the Research Team?
Daniel Sessler, MD
Principal Investigator
The Cleveland Clinic
Are You a Good Fit for This Trial?
This trial is for adults over 18 who are in stable physical condition and scheduled for major noncardiac surgery that requires a hospital stay. They should need significant pain relief post-surgery but can't be chronic opioid users, have certain health conditions, or be unable to consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Oliceridine for pain control and are monitored for respiratory compromise
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Oliceridine
Oliceridine is already approved in United States for the following indications:
- Management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor