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

NCT ID: NCT06530563

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 606 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-05-31

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. 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

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 respiratory depression, postoperative nausea and vomiting and sedation. If a drug is effective treatment of postoperative pain and avoid these adverse reactions, it will shorten the postoperative recovery time of patients, increase patients' satisfaction, and reduce hospitalization costs. Basic research shows that traditional opioids mainly bind to μ-opioid receptors and activate G protein signal transduction to exert analgesic effect. In addition, they stimulate the recruitment of β-arrestin, leading to respiratory depression, nausea and vomiting and other side effects. Oliceridine is a newly μ-opioid receptor agonist, which mainly activates the G protein signaling pathway to exert analgesic effect, but has a weak recruitment effect on β-arrestin and thus reduces the incidence of adverse reactions. However, due to its recent introduction to the market, there is still a lack of large-scale clinical studies on the application of Oliceridine in the population. So this topic to discuss the analgesic efficacy and adverse reactions of Oliceridine in patients with acute pain after abdominal surgery. Our study hypothesized that Oliceridine would have comparable analgesic efficacy and a lower incidence of associated side effects than sufentanil.

Conditions

Acute Pain; Opioid Analgesic Adverse Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oliceridine

In the experimental group, the acute pain after surgery will be treated with Oliceridine, Dexmedetomidine, Ondansetron via patient controlled analgesia for 48 hours. Oliceridine 0.4-0.6mg/kg, Dexmedetomidine 2ug/kg, and Ondansetron 16mg will be supplied to 100ml analgesia pump, loading dose for 2ml, background infusion dose for 1-2ml/h, bolus for 2ml/ time, locked for 15min, maximum dose for 12ml/h.

Group Type: EXPERIMENTAL

Oliceridine Injection [Olinvyk]

Intervention Type: DRUG

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

In the control group, the acute pain after surgery will be treated with Sufentanil, Dexmedetomidine, and Ondansetron via patient controlled analgesia for 48 hours. Sufentanil 2ug/kg , Dexmedetomidine 2ug/kg, and Ondansetron 16mg will be supplied to 100ml analgesia pump, loading dose for 2ml, background infusion dose for 1-2ml/h, bolus for 2ml/ time, locked for 15min, maximum dose for 12ml/h.

Group Type: ACTIVE_COMPARATOR

Sufentanil Citrate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Oliceridine fumarate injection; H20233508; sufentanil injection

Eligibility Criteria

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.

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. 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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wu Jieping Medical Foundation

OTHER

Sponsor Role: collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

e wang, doctor

Role: PRINCIPAL_INVESTIGATOR

Xiangya Hospital of Central South University

Locations

Xiangya Hospital of Central South University

Changsha, Hunan, China

Countries

China

Central Contacts

shinan deng, master

Role: CONTACT

2667806135@qq.com

18890362081

e wang, doctor

Role: CONTACT

ewang324@163.com

18874889950

Facility Contacts

e wang, doctor

Role: primary

ewang324@163.com

18874889950

Other Identifiers

XiangyaHMZK

Identifier Type: -

Identifier Source: org_study_id