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

NCT06530563 · tracked via the Priya Life Science China tracker

Sponsor

Xiangya Hospital of Central South University

Phase

Phase 4

Started

2025-08

Last updated

2025-08-19

Condition(s) studied

Acute PainOpioid Analgesic Adverse Reaction

Investigational drug(s) / intervention(s)

Oliceridine Injection [Olinvyk] →Sufentanil Citrate →

Oliceridine Injection [Olinvyk]: Oliceridine fumarate injection, specifications: 1mg/1mL, 2mg/2 mL, 10mg/10 mL; Stored in the dark, 15-30 ℃, not frozen; Jiangsu Nhwa pharmaceutical co., LTD. Production. Dexmedetomidine, specifications: 200ug/2ml; Ondansetron, specifications: 8mg/4ml.

Sufentanil Citrate: Sufentanil Citrate injection, specification: 50 ug/ml, 1 ml; Avoid light seal; Yichang humanwell pharmaceutical co., LTD. Dexmedetomidine, specifications: 200ug/2ml; Ondansetron, specifications: 8mg/4ml.

Study 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

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1.Preoperative inclusion criteria 1. aged ≥18 years and ≤75 years at screening; 2. Plan to undergo open or laparoscopic abdominal surgery, and the estimated operative time more than 2 hours. 3. able to understand and comply with research procedures and requirements, and can provide a written informed consent. 2.postoperative inclusion criteria: 1. patients who required open or laparoscopic surgery; 2. 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: 1.preoperative exclusion criteria: 1. ASA grade \>III 2. existing other acute or chronic pain conditions; 3. body mass index (BMI) \< 18 or \> 30 kg/m2; 4. 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: 1. intraoperative, postoperative or anesthetic deviations that may affect the efficacy and safety evaluation in the study; 2. evidence of hemodynamic instability or respiratory insufficiency.

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
Xiangya Hospital of Central South University	Changsha	Hunan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06530563 on ClinicalTrials.gov ↗ ← All trials in China