NCT06530563

the Efficacy and Safety of Oliceridine Fumarate Injection for Acute Pain After Abdominal Surgery

the Efficacy and Safety of Oliceridine Fumarate Injection for Acute Pain After Abdominal Surgery: a Randomized, Double-blind, Positive-drug Parallel-controlled, Multi-center Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 606 (estimated)
• Sponsor: Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if Oliceridine fumarate injection works to treat acute pain after abdominal surgery. It will also learn about the safety of Oliceridine fumarate injection. The main questions it aims to answer are: 1. Does Oliceridine fumarate injection works to treat acute pain after abdominal surgery? 2. Does Oliceridine fumarate injection lead to less adverse effect? Researchers will compare Oliceridine fumarate injection to a positive-drug (Sufentanil Citrate) to see if Oliceridine fumarate injection not inferior to sufentanil in the efficacy and safety for acute pain after abdominal surgery. Participants will: 1. Receive patient controlled analgesia treat using Oliceridine or sufentanil after surgery 2. Be followed up every 6 hours until 48 hours after surgery or before discharge

Detailed description

Traditional opioid, such as morphine, sufentanil , is an important drug treatment of postoperative period of acute pain, but their use is often limited because of significant side effects, such as respiratory depression, postoperative nausea and vomiting and sedation. If a drug is effective treatment of postoperative pain and avoid these adverse reactions, it will shorten the postoperative recovery time of patients, increase patients' satisfaction, and reduce hospitalization costs. Basic research shows that traditional opioids mainly bind to μ-opioid receptors and activate G protein signal transduction to exert analgesic effect. In addition, they stimulate the recruitment of β-arrestin, leading to respiratory depression, nausea and vomiting and other side effects. Oliceridine is a newly μ-opioid receptor agonist, which mainly activates the G protein signaling pathway to exert analgesic effect, but has a weak recruitment effect on β-arrestin and thus reduces the incidence of adverse reactions. However, due to its recent introduction to the market, there is still a lack of large-scale clinical studies on the application of Oliceridine in the population. So this topic to discuss the analgesic efficacy and adverse reactions of Oliceridine in patients with acute pain after abdominal surgery. Our study hypothesized that Oliceridine would have comparable analgesic efficacy and a lower incidence of associated side effects than sufentanil.

Conditions

• Acute Pain
• Opioid Analgesic Adverse Reaction

Interventions

Type	Name	Description
DRUG	Oliceridine Injection [Olinvyk]	Oliceridine fumarate injection, specifications: 1mg/1mL, 2mg/2 mL, 10mg/10 mL; Stored in the dark, 15-30 ℃, not frozen; Jiangsu Nhwa pharmaceutical co., LTD. Production. Dexmedetomidine, specifications: 200ug/2ml; Ondansetron, specifications: 8mg/4ml.
DRUG	Sufentanil Citrate	Sufentanil Citrate injection, specification: 50 ug/ml, 1 ml; Avoid light seal; Yichang humanwell pharmaceutical co., LTD. Dexmedetomidine, specifications: 200ug/2ml; Ondansetron, specifications: 8mg/4ml.

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-04-01
• Completion: 2026-05-01
• First posted: 2024-07-31
• Last updated: 2025-08-19

Locations

1 site across 1 country: China