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

StatusNot Yet Recruiting
PhasePhase 4
Started
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Record status
This record was last updated August 19, 2025 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Start date: Aug 2024 to Aug 2025v2 Show 5 more changesShow less
    • Primary endpoint revised
    • Primary completion date: Dec 31, 2025 to Apr 2026
    • Study completion date: Dec 31, 2025 to May 2026
    • Eligibility criteria shortened, about 286 words
    • Secondary endpoints: 8 to 10
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06530563
Lead Sponsor Xiangya Hospital of Central South University
Collaborators: Wu Jieping Medical Foundation
Conditions
(from sponsor)		 Acute Pain, Opioid Analgesic Adverse Reaction
Related terms Acute Pain
Enrollment 606 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov