The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Phase
Phase 4
Started
2024-08-01
Last updated
2025-02-17
Condition(s) studied
Postoperative Pain
Investigational drug(s) / intervention(s)
Low dose oxelidine groupHigh dose oxelidine groupHydromorphone group
Low dose oxelidine group: Analgesic dose
High dose oxelidine group: Analgesic dose
Hydromorphone group: Analgesic dose
Study 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
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Pain score at rest 0-72 hours after surgery — 1 h (hour), 6 h,12 h,18 h,24 h,32 h,40 h,48 h,60 h,72 h (hours) after surgery Patients' pain scores at rest were recorded from 0-72 hours after surgery.
Trial sites (1)
Facility
City
Region
Status
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu
Zhejiang
Recruiting
More The Fourth Affiliated Hospital of Zhejiang University School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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