Hepatocellular carcinoma
Conditions
Interventions
Experimental group:Hydromorphone PCA
Control group:Morphine analgesia on demand
Sponsors
The Cancer Hospital of the University of Chinese Academy of Sciences(Zhejiang Cancer Hospital)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for hepatocellular carcinoma according to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 edition); 2. Meets the indications for TACE; 3. Child-Pugh class A or B (score <= 7); 4. Aged between 18 and 80 years, any gender; 5. ECOG-PS score of 0–2; 6. American Society of Anesthesiologists (ASA) physical status classification I–III; 7. Willing to participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Severe liver dysfunction, including severe jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome; 2. Severe coagulation dysfunction that cannot be corrected; 3. Main portal vein completely obstructed by tumor thrombus, with few collateral vessels and impossible portal vein stenting to restore blood flow to the liver; 4. Concurrent active hepatitis or severe infection that cannot be treated simultaneously; 5. Diffuse tumor or extensive distant metastasis, with an expected survival of 2, cachexia, or multi-organ failure; 7. Renal dysfunction, serum creatinine >176.8 µmol/L or creatinine clearance <30 ml/min; 8. Significant reduction in peripheral blood white blood cells and platelets due to chemotherapy or other drugs, with WBC <3.0×10^9/L and platelets <50×10^9/L that cannot be corrected; 9. Patients with paralytic intestinal obstruction; 10. Use of monoamine oxidase inhibitors within 14 days before randomization; 11. Allergic to the investigational drug or any excipients or contrast agents; 12. History of drug abuse, psychiatric disorders, or long-term use of analgesics, or chronic alcohol consumption; 13. Pregnant or breastfeeding women; subjects planning pregnancy within 1 month after the study (including male subjects); 14. Other diseases and conditions that the investigator considers unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean pain score; | — |
Secondary
| Measure | Time frame |
|---|---|
| NRS values at each measurement time point;Number of occurrences of explosive pain;Satisfaction evaluation;Analgesic medication dosage;Remedial medication dosage;Postoperative length of hospital stay for patients;Willingness to receive interventional treatment again after discharge;EORTC Quality of Life Measurement Scale QLQ-C30 (V3.0); | — |
Countries
China
Contacts
Public ContactLuo Jun
The Cancer Hospital of the University of Chinese Academy of Sciences(Zhejiang Cancer Hospital),Institute of Basic Medicine and Cancer(IBMC),Chinese Academy of Sciences
Outcome results
None listed