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Clinical study of oxelidine versus sufentanil in pain management after knee arthroplasty: A multicenter, prospective, randomized controlled study

Clinical study of oxelidine versus sufentanil in pain management after knee arthroplasty: A multicenter, prospective, randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110632
Enrollment
Unknown
Registered
2025-10-16
Start date
2025-10-31
Completion date
Unknown
Last updated
2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

orthopedic knee replacement surgery

Interventions

Control group (Sufentanil group):Control group: Loading dose: 7.5µg of sufentanil was intravenously injected. After 10 minutes of loading dose, 48-hour PCIA was initiated. 2.5µg/kg was mixed with norm
Experimental group (Othelidine group):Experimental group: Loading dose: Intravenous injection of oxelidine 1.5mg. After 10 minutes of loading dose, 48-hour PCIA was initiated. 0.5mg/kg was mixed with

Sponsors

The Third Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for orthopedic knee replacement surgery; 2. Age: 60-75 years old, gender not limited; 3. ASA classification grades I - III; 4. BMI 18-30kg / m^2; 5. Normal preoperative cognitive function can cooperate with subsequent studies and scale evaluations; 6. Agree to apply the postoperative analgesic pump.

Exclusion criteria

Exclusion criteria: 1. There were already other acute or chronic pains before the operation; 2. Advanced tumors with ascites or extensive metastasis, or those undergoing systemic chemotherapy or radiotherapy, or requiring hyperthermic perfusion after surgery; 3. There is severe liver and kidney dysfunction as well as coagulation disorders; 4. Allergic to or contraindicated to the anesthetics, adjuvant analgesics, remedial analgesics, antiemetic drugs and antibiotics used in the study; 5. Long-term opioid treatment or the use of any analgesics within 48 hours before the operation; Suffer from sleep apnea syndrome; 6. Suffering from mental and neurological disorders, gastrointestinal obstruction, chronic obstructive pulmonary disease or pulmonary heart disease, cardiovascular diseases, etc; 7. Oral, inhaled or parenteral injection of corticosteroids should be administered within 3 months before the operation.

Design outcomes

Primary

MeasureTime frame
NRS score;

Secondary

MeasureTime frame
The incidence of respiratory depression;Postoperative adverse events;Postoperative hemodynamic manifestations such as heart rate and blood pressure;Sedation score and adverse respiratory events;Quality of Recovery-15 (QoR-15);Postoperative remedial analgesia conditions: the time of the first remedial analgesia, the number of remedial analgesia within 48 hours, and the total amount of remedial analgesia drugs;The incidence of nausea and vomiting;Time to first defecation postoperatively: The time interval from the end of surgery to the first defecation;Time to first ambulation postoperatively: The time from the end of surgery to the first ambulation;Length of hospital stay: Number of days from hospital admission to discharge;Patient satisfaction;

Countries

China

Contacts

Public ContactWang Xiuli

The Third Hospital of Hebei Medical University

wangxl301@aliyun.com+86 185 3311 2928

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026