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Recruiting Phase 4 NCT06320041

Efficacy and Safety of Oliceridine for Moderate to Severe Acute Pain After Orthopedic Surgery

Trial Parameters

Condition Postoperative Pain
Sponsor The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 162
Sex ALL
Min Age 18 Years
Max Age 100 Years
Start Date 2024-08-01
Completion 2026-12-31
Interventions
Low dose oxelidine groupHigh dose oxelidine groupHydromorphone group

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

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