Acute PainPhase 4NCT06530563
the Efficacy and Safety of Oliceridine Fumarate Injection for Acute Pain After Abdominal Surgery
A Phase 4 study testing Oliceridine Injection [Olinvyk] and Sufentanil Citrate in people with Acute Pain and Opioid Analgesic Adverse Reaction, run by Xiangya Hospital of Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Pain, Opioid Analgesic Adverse Reaction
- What is being tested?
- Oliceridine Injection [Olinvyk] and Sufentanil Citrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 606 participants
- Where
- 1 siteChina
- Study dates
- Aug 2025to May 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.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.
- 2.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;
Who cannot join
- 1.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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xiangya Hospital of Central South University
Changsha, Hunan, 410000
e wang, doctor, 18874889950, ewang324@163.com
About this study
Official title: the Efficacy and Safety of Oliceridine Fumarate Injection for Acute Pain After Abdominal Surgery: a Randomized, Double-blind, Positive-drug Parallel-controlled, Multi-center Clinical Study
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:
- Does Oliceridine fumarate injection works to treat acute pain after abdominal surgery?
- Does Oliceridine fumarate injection lead to less adverse effect?
Read more
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:
- Receive patient controlled analgesia treat using Oliceridine or sufentanil after surgery
- Be followed up every 6 hours until 48 hours after surgery or before discharge
Read the 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
- Being tested
- Oliceridine Injection [Olinvyk], Sufentanil Citrate
- Keywords
- Oliceridine, acute pain after surgery, abdominal surgery
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oliceridine Injection [Olinvyk]Drug
Also called Oliceridine fumarate injection, H20233508
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 CitrateDrug
Also called sufentanil injection
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Sufentanil Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Area under the pain intensity time curve (AUC) in resting and moving states as assessed by NRS during postoperative 12 and 24 hours
Measured: 12 or 24 hours
total dose of rescue analgesics within 48 hours
rescue analgesics include flurbiprofen axetil injection, parecoxib sodium and ketorolac tromethamine, reported in mg.
Measured: 48 hours or the liquid of pump has run out before 48 hours.
proportion of patients used rescue analgesics
proportion of patients used rescue analgesics
Measured: 48 hours or when the liquid of pump has run out before 48 hours.
Incidence of respiratory depression
Incidence of respiratory depression (i.e., respiratory rate ≤8 breaths/minute or oxygen saturation (SpO2)<90%)
Measured: 48 hours
The occurrence of nausea and vomiting
The proportion of patients with nausea and vomiting within 48 hours and the proportion of patients using antiemetic drugs. Antiemetic drugs (i.e., ondansetron or tropisetron) report in mg.
Measured: 48 hours
Condition of sedation
Condition of sedation is assessed by observer's assessment alert/Sedation(OAA/S), value from 0 to 5, grade 0 means deep sedation, grade 5 means fully awake.
Measured: 48 hours
the occurrence of adverse events
the occurrence of adverse events
Measured: 1 month
Satisfaction scores within 48 h of the participants and researchers
Satisfaction scores grade from 1 to 5. 5 means very satisfied, 4 means satisfied, 3 means general satisfied, 2 means not satisfied, 1 means very dissatisfied.
Measured: 48 hours
the use of Antiemetic drugs
the use of antiemetic drugs.
Measured: 48 hours
the score of quality of recovery-15 items
the score of quality of recovery-15 items(QoR-15)
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study startAug 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 606 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Wu Jieping Medical Foundation
- Responsible party
- Sponsor
- Investigators
- e wang, doctor, Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530563
- Sponsor's protocol ID
- XiangyaHMZK
- Status last verified
- Aug 2025
- First submitted
- 22 Jul 2024
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Efficacy and Safety of Oliceridine Fumarate Injection for Acute Pain After Abdominal Surgery: a Randomized, Double-blind, Positive-drug Parallel-controlled, Multi-center Clinical Study
- ClinicalTrials.gov ID
- NCT06530563
- Acronym / sponsor ID
- XiangyaHMZK
- Conditions
- Acute Pain, Opioid Analgesic Adverse Reaction
- Keywords
- Oliceridine, acute pain after surgery, abdominal surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 606 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Wu Jieping Medical Foundation
- Study start
- Aug 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does Oliceridine fumarate injection works to treat acute pain after abdominal surgery?
- 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:
- Receive patient controlled analgesia treat using Oliceridine or sufentanil after surgery
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oliceridine | Experimental | Drug: Oliceridine Injection [Olinvyk]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. |
| Sufentanil | Active comparator | Drug: Sufentanil CitrateIn 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1.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.
- patients who required open or laparoscopic surgery;
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oliceridine Injection [Olinvyk]Also: Oliceridine fumarate injection, H20233508Oliceridine 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. | Drug | Oliceridine |
| Sufentanil CitrateAlso: sufentanil injectionSufentanil Citrate injection, specification: 50 ug/ml, 1 ml; Avoid light seal; Yichang humanwell pharmaceutical co., LTD. Dexmedetomidine, specifications: 200ug/2ml; Ondansetron, specifications: 8mg/4ml. | Drug | Sufentanil |
Primary outcome
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
Time frame: 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.
10 secondary outcomes
Area under the pain intensity time curve (AUC) in resting and moving states as assessed by NRS during postoperative 12 hours and 24 hours.
Time frame: 12 or 24 hours
total dose of rescue analgesics within 48 hours
Time frame: 48 hours or the liquid of pump has run out before 48 hours.
proportion of patients used rescue analgesics
Time frame: 48 hours or when the liquid of pump has run out before 48 hours.
Incidence of respiratory depression
Time frame: 48 hours
The occurrence of nausea and vomiting
Time frame: 48 hours
Condition of sedation
Time frame: 48 hours
the occurrence of adverse events
Time frame: 1 month
Satisfaction scores within 48 h of the participants and researchers
Time frame: 48 hours
the use of Antiemetic drugs
Time frame: 48 hours
the score of quality of recovery-15 items
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
e wang, doctor principal investigator
Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oliceridine Injection [Olinvyk] and Sufentanil Citrate in people with Acute Pain and Opioid Analgesic Adverse Reaction, run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact shinan deng, master (18890362081, 2667806135@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.