RecruitingPhase 4NCT06320041

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


Sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Enrollment

162 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria2

  • elective orthopedic surgery under general anesthesia.
  • The patient can communicate normally and has the correct expression of pain

Exclusion Criteria10

  • Patients with advanced tumor
  • Other acute and chronic pain conditions are present
  • Severely obese (30 kg/m2)
  • Pregnant or lactating women
  • Allergy to opioids
  • Sleep apnea syndrome
  • Long-term opioid treatment
  • Patients with mental and nervous system diseases, gastrointestinal obstruction, chronic obstructive pulmonary disease or pulmonary heart disease, cardiovascular disease
  • Abnormal liver function during screening
  • Abnormal renal function during screening

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Interventions

DRUGLow dose oxelidine group

Analgesic dose

DRUGHigh dose oxelidine group

Analgesic dose

DRUGHydromorphone group

Analgesic dose


Locations(1)

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, China

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NCT06320041


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