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

NCT06530563 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: XiangyaHMZK
• Study Type: interventional
• Target: 606
• Locations: 1 country
• Sites: 1

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. 1.Does Oliceridine fumarate injection works to treat acute pain after abdominal surgery?
2. 2.Does Oliceridine fumarate injection lead to less adverse effect?
3. 3.Receive patient controlled analgesia treat using Oliceridine or sufentanil after surgery
4. 4.Be followed up every 6 hours until 48 hours after surgery or before discharge

Conditions

Acute Pain; Opioid Analgesic Adverse Reaction

Keywords

Oliceridine; acute pain after surgery; abdominal surgery

Outcome Measures

Primary Outcomes (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

  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.

  48 hours

Secondary Outcomes (10)

• Area under the pain intensity time curve (AUC) in resting and moving states as assessed by NRS during postoperative 12 hours and 24 hours.

  12 or 24 hours

• total dose of rescue analgesics within 48 hours

  48 hours or the liquid of pump has run out before 48 hours.

• proportion of patients used rescue analgesics

  48 hours or when the liquid of pump has run out before 48 hours.

• Incidence of respiratory depression

  48 hours

• The occurrence of nausea and vomiting

  48 hours

Other Outcomes (1)

• the analgesic effect and adverse reactions of Oliceridine in preoperative and postoperative hypertensive patients taking angiotensin-converting enzyme inhibitor/angiotensin receptor blocker(ACEI/ARB) drugs

  1 month

Study Arms (2)

Oliceridine

EXPERIMENTAL

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.

Drug: Oliceridine Injection [Olinvyk]

Sufentanil

ACTIVE COMPARATOR

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.

Drug: Sufentanil Citrate

Interventions

Oliceridine Injection [Olinvyk] 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.

Also known as: Oliceridine fumarate injection, H20233508

Oliceridine

Sufentanil Citrate 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.

Also known as: sufentanil injection

Sufentanil

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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;

You may not qualify if:

• 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;
• \) 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.
• intraoperative, postoperative or anesthetic deviations that may affect the efficacy and safety evaluation in the study;
• evidence of hemodynamic instability or respiratory insufficiency.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead
• Wu Jieping Medical Foundation: collaborator

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location

MeSH Terms

Conditions

Acute Pain

Interventions

((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine; Sufentanil

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• e wang, doctor

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

shinan deng, master

CONTACT

18890362081; 2667806135@qq.com

e wang, doctor

CONTACT

18874889950; ewang324@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 31, 2024
• Study Start: August 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)