NCT06320041 Efficacy and Safety of Oliceridine for Moderate to Severe Acute Pain After Orthopedic Surgery
| NCT ID | NCT06320041 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The Fourth Affiliated Hospital of Zhejiang University School of Medicine |
| Condition | Postoperative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 162 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 162 participants in total. It began in 2024-08-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial\] is to further explore the effectiveness and safety of oxelidine in the treatment of moderate to severe acute pain after orthopedic surgery. The main question it aims to answer is: Pain management after orthopaedic surgery provides more effective and safe drug options, provides new options for clinical treatment, and provides a scientific basis for clinical practice. Participants will be asked to pain score in the different time, treatments they'll be given and use optimal drug. Researchers will compare analgesic effect of oxelidine of different dose.
Eligibility Criteria
Inclusion Criteria: 1. elective orthopedic surgery under general anesthesia. 2. The patient can communicate normally and has the correct expression of pain Exclusion Criteria: 1. Patients with advanced tumor 2. Other acute and chronic pain conditions are present 3. Severely obese (30 kg/m2) 4. Pregnant or lactating women 5. Allergy to opioids 6. Sleep apnea syndrome 7. Long-term opioid treatment 8. Patients with mental and nervous system diseases, gastrointestinal obstruction, chronic obstructive pulmonary disease or pulmonary heart disease, cardiovascular disease 9. Abnormal liver function during screening 10. Abnormal renal function during screening
Contact & Investigator
Dongmei Ma
STUDY CHAIR
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Frequently Asked Questions
Who can join the NCT06320041 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06320041 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06320041 currently recruiting?
Yes, NCT06320041 is actively recruiting participants. Contact the research team at 8019111@zju.edu.cn for enrollment information.
Where is the NCT06320041 trial being conducted?
This trial is being conducted at Yiwu, China.
Who is sponsoring the NCT06320041 clinical trial?
NCT06320041 is sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine. The principal investigator is Dongmei Ma at The Fourth Affiliated Hospital of Zhejiang University School of Medicine. The trial plans to enroll 162 participants.