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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. existing other acute or chronic pain conditions;
. body mass index (BMI) \< 18 or \> 30 kg/m2;
. 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.