lumbar spondylopathy
Conditions
Interventions
Oliceridine group:The formulation and parameters of postoperative PCA analgesia were as follows:
0.5 mg/kg oliceridine diluted with normal saline to 100 mL.
Loading dose: 0.03 mg/kg oliceridine admini
Sufentanil group:The formulation and parameters of postoperative PCA analgesia were as follows:
1.5 µg/kg sufentanil diluted with normal saline to 100 mL.
Loading dose: 0.1 µg/kg sufentanil administer
Sponsors
The Affiliated Hospital of Xuzhou Medical University,Xijing Hospital,;Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Patients undergoing lumbar spine surgery (within 3 segments) under general anesthesia, and scheduled to receive patient-controlled analgesia postoperatively; 3. ASA physical status class I–III; 4. BMI 18–30 kg/m^2; 5. Obtained written informed consent from the patient.
Exclusion criteria
Exclusion criteria: 1. Use of any analgesics within 3 days before surgery, or long-term treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) (daily use of NSAIDs for more than 2 consecutive weeks within 3 months before surgery); 2. Presence or suspicion of intestinal obstruction: nausea and vomiting, abdominal distension or pain, cessation of flatus or defecation within the past two weeks, or imaging evidence of intestinal dilatation and large gas-fluid levels; 3. Patients with severe hepatic insufficiency (Child-Pugh class C); 4. Previous or planned gastrointestinal surgery; 5. Patients with hypersensitivity to the study drug; 6. Pregnant or lactating patients; 7. Abnormal QTcF interval: > 450 ms in males and > 470 ms in females; 8. Participation in another clinical trial within the past 30 days; 9. Long-term opioid use (administration of > 15 mg morphine equivalent daily for more than 3 days per week over a period of > 1 month within 12 months before surgery); 10. Underlying neuropsychiatric disorders: e.g., epilepsy, depression, schizophrenia, etc.; 11. Patients judged by the investigator to be unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who achieved the GI-3 composite endpoint (tolerating solid diet and passage of flatus/stool) within 24 hours postoperatively.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients who achieved the GI-3 composite endpoint (tolerating solid diet and passage of flatus/stool) within 48 hours postoperatively.;GI-3: The time of the later one of the following two time points: 1. Time to solid food tolerance: no vomiting within 4 hours after ingestion of food requiring chewing; 2. Time to first flatus or first defecation (the shorter of the two values).;IFEED scores at 24 and 48 hours postoperatively;Postoperative SPID-24 and SPID-48 (Summed Pain Intensity Difference, the time weighted sum of pain intensity differences);Opioid consumption at 24 and 48 hours postoperatively (expressed as morphine equivalents);Number of rescue analgesic administrations within 48 hours postoperatively; | — |
Countries
China
Contacts
Public ContactJunli Cao;Hailong Dong
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed