Oliceridine for Major Surgery

No longer recruiting at 2 trial locations

Overseen By Roberta Johnson

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: The Cleveland Clinic

Must not be taking: Gabapentin, Pregabalin, others

Disqualifiers: Dementia, Chronic opioid use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 48 hours

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. ^{1 2 3 4 5}

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. ^{3 6 7 8 9}

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

My health is good enough for surgery, but I may have serious health problems.

I need strong pain medication equivalent to 20 mg of morphine or more.

I am scheduled for surgery with general or spinal anesthesia.

Exclusion Criteria

Are known to be pregnant or breastfeeding

Have language, vision, or hearing impairments that may compromise continuous ventilation monitoring

I use oxygen at home.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Oliceridine for pain control and are monitored for respiratory compromise

48 hours

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Oliceridine

Trial Overview

The study is testing the side effects of Oliceridine, an intravenous medication given to manage pain after major surgeries. It's focused on how well it works and what adverse reactions patients might experience.

How Is the Trial Designed?

Group I: Oliceridine Experimental Treatment 1 Intervention

Patients receive Oliceridine for pain control.

Oliceridine is already approved in United States for the following indications:

Approved in United States as Olinvyk for:

• Management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

OpenVigil FDA is a new web-based tool that simplifies access to pharmacovigilance data, allowing healthcare professionals to analyze drug safety and adverse events without needing special licenses or complex statistical software.

The tool enables users to perform various analyses, such as identifying drugs linked to adverse events and comparing safety profiles, making it a practical resource for clinicians to address real-life clinical issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OpenVigil FDA - Inspection of U.S. American Adverse Drug Events Pharmacovigilance Data and Novel Clinical Applications. Böhm, R., von Hehn, L., Herdegen, T., et al.[2022]

A study analyzing 4,339 adverse events (AEs) associated with radium-223 from the Eudra-Vigilance database found that the most common AEs were hematological, general, and gastrointestinal disorders, with over 90% classified as serious and 8% fatal.

Older patients (over 85 years) treated with radium-223 showed a higher risk of cardiac, infectious, and metabolic disorders compared to younger patients, indicating the need for careful monitoring in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events related to radium-223 treatment: "real-life" data from the Eudra-Vigilance database. Tema, G., Lombardo, R., Voglino, O., et al.[2021]

Sugammadex is associated with fewer cases of bradycardia compared to neostigmine in pediatric patients, indicating a potentially safer profile for reversing neuromuscular blockade.

The use of sugammadex resulted in significantly shorter recovery times from anesthesia, especially in neonates, suggesting it is more effective than neostigmine for this purpose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Analysis of the Safety and Efficacy of Sugammadex Versus Neostigmine for the Reversal of Neuromuscular Blockade in Children. Gaver, RS., Brenn, BR., Gartley, A., et al.[2020]

MetaADEDB 2.0 is an updated online database that now includes 744,709 drug-adverse drug event (ADE) associations, representing a 40% increase from its previous version, making it a more comprehensive resource for researchers.

The new version features a user-friendly web interface, enhancing accessibility for drug safety assessments and studies in drug discovery and development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MetaADEDB 2.0: a comprehensive database on adverse drug events. Yu, Z., Wu, Z., Li, W., et al.[2021]

A large analysis of adverse event reports revealed that tofacitinib/XR had significantly higher rates of cardiovascular-related (14.1%) and blood clot-related (14.8%) events compared to baricitinib and upadacitinib, indicating potential safety concerns for this medication.

Baricitinib was associated with the highest proportions of death (7.2%) and cancer-related (4.1%) adverse events, suggesting that while all three drugs are in the same class, their safety profiles may differ significantly, warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of adverse event reporting of Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to the US Food and Drug Administration. Qian, J., Xue, X., Shannon, J.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12209531/

Overview and Prospects of the Clinical Application ...

This review synthesizes current evidence on oliceridine's efficacy, safety, and mechanistic specificity across diverse surgical settings.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0952818025001308

Oliceridine for postoperative pain and opioid-related ...

In acute postoperative pain studies, oliceridine efficacy was superior to placebo and noninferior to morphine [10,11,12,13]. Evidence from clinical trials ...

3.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0299320

Efficacy, safety, and side effects of oliceridine in acute ...

This will be the first meta-analysis on the efficacy, safety, and side effects of oliceridine on postoperative pain.

4.

bmjopen.bmj.com

bmjopen.bmj.com/content/15/9/e106066

The effects of oliceridine and sufentanil on postoperative ...

Wang et al evaluated the safety and efficacy of oliceridine for moderate-to-severe postoperative pain following abdominal surgery.

5.

nature.com

nature.com/articles/s41598-025-95978-9

Tolerability of different doses of oliceridine versus ...

The systematic review and meta-analysis reveal that oliceridine is a well-tolerated and safe intravenous analgesic for acute pain patients.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12258402/

Evaluating the Opioid-Related Adverse Events of Oliceridine ...

These results indicate that oliceridine is associated with a lower risk of ORADEs and PONV compared to conventional opioids, while other ...

7.

trevena.com

trevena.com/investors/press-releases/detail/318/trevena-announces-initial-topline-olinvyk-data-from-~200-patient-real-world-clinical-outcomes-study

Trevena Announces Initial Topline OLINVYK Data from

OLINVYK-treated patients had a statistically significant 1.6 day (~27%) reduction in average overall hospital length of stay compared to matched ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40446423/

Oliceridine for postoperative pain and opioid-related ...

Conclusion: Nearly one quarter of patients experienced a respiratory compromise with oliceridine analgesia, none of which was life-threatening.

9.

dig.pharmacy.uic.edu

dig.pharmacy.uic.edu/faqs/2020-2/december-2020-faqs/what-evidence-supports-the-use-of-oliceridine-for-severe-pain/

What evidence supports the use of oliceridine for severe pain?

As for safety outcomes, oliceridine failed to show a superior RSB as compared to morphine.7,8 Generally, the impact of oliceridine on ...