Acute postoperative pain
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 years or older; 2. ASA = 18 kg/m^2 and = 2 hours, hospitalization >= 3 days), including specific types of surgery such as colorectal, gastric, pancreatic, and complex gynecologic tumor surgeries planned via transfemoral TAVR approach; 5. Expected surgery duration >= 1 hour and <= 3 hours; 6. No need for other types of surgery; 7. Signed informed consent; 8. Able to understand the procedures and methods of this trial, willing to strictly comply with the clinical research protocol, and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Individuals with contraindications to anesthesia/sedation or a history of adverse reactions to anesthesia/sedation; 2. Those with known contraindications to opioids and their antagonists; 3. Excluding patients who have undergone nephrectomy, hepatectomy, emergency surgery, or minor laparoscopic procedures (e.g., laparoscopic cholecystectomy); 4. Severe liver dysfunction (Child-Pugh class C) or renal insufficiency (eGFR < 30 mL/min/1.73m^2); 5. History of severe nausea and vomiting, or gastrointestinal motility disorders such as gastroparesis; 6. Severe cardiopulmonary dysfunction or sleep apnea; 7. Shock during the screening period or hypotension that is difficult to correct with vasoactive drugs; 8. History of neurological or psychiatric disorders: traumatic brain injury, convulsions, epilepsy, intracranial hypertension, cerebral aneurysm, cerebrovascular accident; or schizophrenia, mania, long-term use of psychiatric medications, or cognitive impairment; 9. Patients planning postoperative ICU admission; 10. Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of PONV within 72 hours postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of PONV;Incidence of PONV, time to first episode, and requirement for rescue antiemetics;Rate of gastrointestinal function recovery within 72 hours postoperatively (measured by GI-3 recovery);Time to GI-3 recovery, time to GI-2 recovery;Time to first flatus, time to first bowel movement, time to first oral intake of liquids;Incidence of postoperative ileus (defined as failure to achieve GI-3 by 120 hours postoperatively);Numeric Rating Scale Score;Frequency and dosage of rescue analgesics;Postoperative opioid consumption;Quality of Recovery-15 (QoR-15) score;Time to meet medically defined discharge criteria;Inflammatory markers (CRP, IL-6, TNF-a);Total length of hospital stay within 30 days postoperatively;Unplanned readmission within 30 days postoperatively;Major surgical complications (Clavien-Dindo classification = Grade 3);30-day and 90-day postoperative mortality rates; | — |
Countries
China
Contacts
The Second Affiliated Hospital, Zhejiang University School of Medicine