Status:
NOT_YET_RECRUITING
the Efficacy and Safety of Oliceridine Fumarate Injection for Acute Pain After Abdominal Surgery
Lead Sponsor:
Xiangya Hospital of Central South University
Collaborating Sponsors:
Wu Jieping Medical Foundation
Conditions:
Acute Pain
Opioid Analgesic Adverse Reaction
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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. ...
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 res...
Eligibility Criteria
Inclusion
- 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
- preoperative exclusion criteria:
- ASA grade \>III
- 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;
- 6\) suffering from mental or nervous system diseases (such as epilepsy, depression, schizophrenia, etc.), chronic obstructive pulmonary disease or pulmonary heart disease, heart failure, severe arrhythmia, etc; 7) with severe liver and kidney dysfunction; 8) Other conditions considered by the investigator to be inappropriate for enrollment.
- Postoperative exclusion criteria:
- intraoperative, postoperative or anesthetic deviations that may affect the efficacy and safety evaluation in the study;
- evidence of hemodynamic instability or respiratory insufficiency.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
606 Patients enrolled
Trial Details
Trial ID
NCT06530563
Start Date
August 1 2025
End Date
May 1 2026
Last Update
August 19 2025
Active Locations (1)
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1
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000