the Efficacy and Safety of Oliceridine Fumarate Injection for Acute Pain After Abdominal Surgery (NCT06530563) | Clinical Trial Compass
Not Yet RecruitingPhase 4
the Efficacy and Safety of Oliceridine Fumarate Injection for Acute Pain After Abdominal Surgery
China606 participantsStarted 2025-08
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓.Preoperative inclusion criteria
✓. aged ≥18 years and ≤75 years at screening;
✓. Plan to undergo open or laparoscopic abdominal surgery, and the estimated operative time more than 2 hours.
✓. able to understand and comply with research procedures and requirements, and can provide a written informed consent.
✓.postoperative inclusion criteria:
✓. patients who required open or laparoscopic surgery;
✓. According to the investigator's judgment, the patient had recovered sufficiently from the intraoperative anesthesia protocol to accurately complete the protocol-specified questionnaire;
Exclusion criteria
✕.preoperative exclusion criteria:
✕. ASA grade \>III
✕. existing other acute or chronic pain conditions;
What they're measuring
1
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
Timeframe: 48 hours
Trial details
NCT IDNCT06530563
SponsorXiangya Hospital of Central South University
✕. with sleep apnea syndrome; 5 ) long-term opioid treatment, defined as receiving more than 15mg morphine equivalent units per day on more than 3 days per week for a period of more than 1 month in the 12 months prior to surgery;
✕. intraoperative, postoperative or anesthetic deviations that may affect the efficacy and safety evaluation in the study;
✕. evidence of hemodynamic instability or respiratory insufficiency.