Last reviewed · How we verify
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
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
Details
| Lead sponsor | Xiangya Hospital of Central South University |
|---|---|
| Phase | Phase 4 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 606 |
| Start date | 2025-08 |
| Completion | 2026-05 |
Conditions
- Acute Pain
- Opioid Analgesic Adverse Reaction
Interventions
- Oliceridine Injection [Olinvyk]
- Sufentanil Citrate
Primary outcomes
- Area under the pain intensity time curve (AUC0-48, time in hours) in resting and moving states as assessed by numerical rating scale(NRS) during postoperative 48 hours — 48 hours
Numerical rating scale(NRS), values from 0 to 10, 0 means "no pain", 10 means "the most intense pain", the higher score means a worse outcome; Area under the pain intensity time curve (AUC0-48), time in hours.
Countries
China