Trauma to the Lower Extremities in the Emergency Setting
Conditions
Interventions
Sufentanil group (Group S):The postoperative analgesia regimen consists of Sufentanil 2.5 µg/kg + Ondansetron 16 mg diluted with normal saline to a total volume of 100 ml. The pump is set with an init
Oliceridine group (Group O):The postoperative analgesia regimen consists of Oliceridine 20 mg + Ondansetron 16 mg diluted with normal saline to a total volume of 100 ml. The pump is set with an initia
Sponsors
The 960th Hospital of PLA
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years, inclusive. 2. American Society of Anesthesiologists (ASA) physical status classification of I–III. 3. Undergoing emergency surgery for acute lower extremity trauma (e.g., tibial/fibular fractures, femoral fractures, etc.). 4. Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Allergy or contraindication to opioids. 2. Severe hepatic or renal insufficiency. 3. Long-term use of opioids or sedative medications. 4. History of substance abuse. 5. Cognitive impairment that prevents cooperation with study procedures. 6. Current pregnancy or lactation (breastfeeding).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of Recovery-15 score at 24 hours postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Respiratory depression (respiratory rate <8 breaths/min or SpO2 <90%);Nausea;Vomiting;Pruritus;Dizziness;Sedation score;Time to first flatus;Time to first defecation;Time to first ambulation;Length of hospital stay after surgery;Total demand presses of patient-controlled intravenous analgesia (PCIA);Effective demand presses of patient-controlled intravenous analgesia (PCIA);Use of rescue analgesics; | — |
Countries
China
Contacts
Public ContactWang Wenzheng
The 960th Hospital of PLA
Outcome results
None listed