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Compare the postoperative analgesic effect of oxycodone and sufentanil in patients with lower extremity fractures

Compare the postoperative analgesic effect of oxycodone and sufentanil in patients with lower extremity fractures

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091258
Enrollment
Unknown
Registered
2024-10-24
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-10-28

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

Conditions

Fracture of lower limb

Interventions

experimental group:1. General anesthesia program: anesthesia induction program is as follows: oxycodone 0.15mg/kg, etomidate 0.3mg/kg, rocuronium bromide 0.8mg/kg, adequate oxygen denitrification afte
if the patients heart rate or blood pressure increases more than 30% of the basal value, oxycodone 0.04mg/kg is injected intravenously, and if the patients blood pressure and heart rate decreases more
control group:In the control group, sufentanil 0.4 µ g /

Sponsors

The Affiliated Yongchuan Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients (age =18 years) with lower extremity fractures requiring surgical treatment, ASA classification I-III.

Exclusion criteria

Exclusion criteria: 1) patients who refuse to participate in the trial; 2) patients allergic to the trial drug or with previous serious adverse reactions; 3) patients with long preoperative sedative or analgesic drugs; 4) patients with previous schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or severe dementia; 5) patients unable to communicate due to hearing, visual or language impairment; 6) patients with severe liver dysfunction (Child-Pugh grade C); 7) patients with severe renal dysfunction (requiring renal replacement therapy); 8) patients with traumatic shock.

Design outcomes

Primary

MeasureTime frame
Postoperative analgesic application of sufentanil or oxycodone in patients undergoing lower extremity fracture surgery on NRS scores at rest at the 3rd, 12th, 24th, and 48th postoperative hours; effects on the incidence of moderate to severe pain (NRS 4) in resting state within 48h ;Incidence of moderate-to-severe pain (NRS=4) in lower extremity activities within 48h after patients fully recovered from anesthesia;Changes in serum cortisol hormone levels and catecholamine epinephrine levels were measured before, during, and within 48h after surgery.5) The number of additional postoperative pressure presses on the analgesic pump and the number of nerve blocks performed;Incidence of postoperative complications such as nausea and vomiting;

Secondary

MeasureTime frame
Time from the end of surgery to the first start of functional exercise;The incidence of deep vein thrombosis in the lower limbs;Postoperative hospital stay;

Countries

China

Contacts

Public Contactlvzhiquan

The Affiliated Yongchuan Hospital of Chongqing Medical University

lzq6656@163.com+86 159 2308 2966

Outcome results

None listed

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