Enhanced Recovery After Surgery, Multimodal Analgesia, Real-world Study, Transarterial Chemoembolization
Conditions
Keywords
Enhanced Recovery After Surgery, Hepatocellular Carcinoma, Transarterial Chemoembolization, Multimodal Analgesia, Real-World Study, Hydromorphone, Flurbiprofen axetil
Brief summary
To evaluate the effectiveness of the combination of hydrochloride hydromorphone and flurbiprofen ester for post-TACE intravenous patient-controlled intravenous analgesia (PCIA).
Detailed description
This multicenter retrospective study analyzed clinical data from 129 patients with intermediate or advanced HCC who underwent TACE at three centers. Patients were divided into perioperative analgesia protocol groups: Group A (n=85) received patient-controlled intravenous analgesia-based multimodal preemptive analgesia (hydromorphone hydrochloride 6 mg, flurbiprofen axetil 50 mg) with background infusion. Group B (n=44) received conventional on-demand analgesia (intraoperative intravenous flurbiprofen axetil 50 mg, intramuscular tramadol 100 mg as needed for pain). Outcome measures included numerical rating pain scale scores, perioperative adverse events, inflammatory markers, hepatic function indicators, analgesia satisfaction, and cost-effectiveness.
Interventions
DRUGhydrochloride hydromorphone + flurbiprofen axetil
Group A received hydromorphone hydrochloride combined with flurbiprofen axetil via PCIA. The pump was initiated 15 min before surgery, with settings of background infusion 2 ml/h, bolus dose 2 ml, and lockout interval 15 min.
When the NRS score was ≥4, flurbiprofen axetil 50 mg was administered intravenously, with intramuscular tramadol 100 mg added if analgesia was inadequate.
Sponsors
Guangzhou Institute of Cancer Reasearch, the Affiliated Cancer Hospital, Guangzhou Medical University
Jinshazhou Hospital of Guangzhou University of Chinese Medicine
First Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Pathologically or clinically diagnosed with hepatocellular carcinoma according to the Guidelines for Diagnosis and Treatment of Primary Liver Cancer issued by the National Health Commission of China in 2024; 2. staged as China Liver Cancer Stage II-III1 or 2022 Barcelona Clinic Liver Cancer stage B-C14; 3. liver function classified as Child-Pugh grade A or B; 4. ECOG PS score 0-215; 5. meeting the following hematological criteria: white blood cell count ≥3×10⁹/L, platelet count ≥50×10⁹/L, hemoglobin ≥80 g/L, serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤twice the upper limit of normal (ULN), serum creatinine ≤1.5×ULN, INR \<1.5 or prothrombin time \<ULN + 4 s, albumin (ALB) ≥30 g/L, total bilirubin \<34 mmol/L.
Exclusion criteria
1. History of iodine contrast allergy; 2. severe psychological or psychiatric disorders; 3. history of long-term analgesic medication use; 4. severe cardiopulmonary disease; 5. severe uncontrolled infection; 6. incomplete medical records.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative numerical pain rating scale (NRS) score | From the start of the operation to 24 hours after the operation | The NRS was used to assess pain intensity intraoperatively, immediately postoperatively, and at 1 h, 4 h, 8 h, 12 h, and 24 h postoperatively, with scores ranging 0-10 (0=no pain, 1-3=mild pain, 4-6=moderate pain, 7-10=severe pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Duration | From the start of the operation to the end of the operation | Total time from puncture initiation to completion of dressing (min). |
| Adverse Events | From the start of the operation to 24 hours after the operation | Adverse events within 24 h postoperatively were recorded, including elevated ALBI scores, ALT and AST \>2×ULN, nausea and vomiting, drowsiness and dizziness, pruritus, and urinary difficulty, with related indicator changes and incidence documented. |
| Analgesia Satisfaction | At 24 hours postoperatively | At 24 h postoperatively, patients' subjective experiences were assessed using a 5-point Likert scale (5=very satisfied, 4=satisfied, 3=neutral, 2=dissatisfied, 1=very dissatisfied). |
| Cost-Effectiveness Analysis | From the start of the operation to the end of perioperative period | TACE perioperative analgesia costs plus postoperative hospitalization costs were used as the cost indicator (C), with analgesia satisfaction ≥4 as the effectiveness indicator (E). The average cost approach was used for incremental cost-effectiveness analysis (ΔC/ΔE). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Serum Inflammatory Markers | preoperatively and on the second postoperative morning | Fasting venous blood was collected preoperatively and on the second postoperative morning to measure procalcitonin (PCT)(ng/ml) and interleukin-6 (IL-6)(pg/ml) levels. |
| Hepatic Function Indicators | preoperatively and on the second postoperative morning | Fasting venous blood was collected preoperatively and on the second postoperative morning to measure serum alanine aminotransferase (ALT)(U/L), aspartate aminotransferase (AST)(U/L), albumin (ALB)(g/L), total bilirubin levels(μmol/L), and ALB-bilirubin (ALBI) scores. |
Countries
China
Outcome results
None listed