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Comparison of Hydromorphone PCA and Conventional Morphine Analgesia during TACE Perioperative Period: A Prospective, Multicenter, Randomized Controlled Clinical Research

Comparison of Hydromorphone PCA and Conventional Morphine Analgesia during TACE Perioperative Period: A Prospective, Multicenter, Randomized Controlled Clinical Research

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105037
Enrollment
Unknown
Registered
2025-06-27
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-06-30

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

Conditions

Perioperative pain during TACE surgery

Interventions

Experimental group:Patient controlled intravenous analgesia with hydromorphone hydrochloride injection
Control group:Morphine hydrochloride injection for on-demand analgesia

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Complies the diagnostic criteria for hepatocellular carcinoma in the Diagnosis and Treatment Guidelines for Primary Liver Cancer (2024 edition); 2.Complies with TACE indications; 3.Opioid intolerant patients; 4.Child Pugh classification A or B (score <= 7 points); 5.Age between 18-80 years old, male or female not limited; 6.ECOG-PS score 0-2 points; 7.The American Society of Anesthesiologists (ASA) classifies it as grades I-III; 8.Voluntarily participate and sign a written informed consent form;

Exclusion criteria

Exclusion criteria: 1.Severe liver dysfunction, including severe jaundice, hepatic encephalopathy, refractory ascites, or hepatorenal syndrome; 2.Severe loss of coagulation function that cannot be corrected; 3.The main portal vein is completely occluded by cancer thrombus, with few collateral vessels formed, and cannot be reopened with portal vein stents to restore blood flow to the liver; 4.Combination of active hepatitis or severe infection that cannot be treated simultaneously; 5.Diffuse or distant metastasis of the tumor, expected survival time2, cachexia or multiple organ failure; 7.Renal dysfunction, blood creatinine>176.8 µ mol/L or creatinine clearance rate= 7 days) use of painkillers, and long-term alcohol abuse; 13.Pregnant and lactating women; Subjects with pregnancy plans within one month after the experiment (including male subjects); 14.Participated in other clinical studies within the past 14 days; 15.Diseases and conditions that other researchers consider ineligible for inclusion;

Design outcomes

Primary

MeasureTime frame
Accumulated pain score for postoperative break-out pain;Incidence of adverse reactions;

Secondary

MeasureTime frame
Number of occurrences of explosive pain;Number of days of hospital stay for postoperative patients;Willingness to re-intervene after discharge;Analgesic drug dosage;Satisfaction rating;Laboratory test markers;NRS values at each measurement time point;Physical examination;EORTC QLQ-C30(V3.0);

Countries

China

Contacts

Public ContactJun Luo

Zhejiang Cancer Hospital

bjy0927@163.com+86 571 88122441

Outcome results

None listed

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