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NCT Number: NCT07315022

Enhanced Recovery After Surgery-Based Multimodal Preemptive Analgesia for Perioperative Management in Transarterial Chemoembolization of Intermediate-to-Advanced Hepatocellular Carcinoma

To evaluate the effectiveness of the combination of hydrochloride hydromorphone and flurbiprofen ester for post-TACE intravenous patient-controlled intravenous analgesia (PCIA).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • staged as China Liver Cancer Stage II-III1 or 2022 Barcelona Clinic Liver Cancer stage B-C14;
  • liver function classified as Child-Pugh grade A or B;
  • ECOG PS score 0-215;
  • 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

  • History of iodine contrast allergy;
  • severe psychological or psychiatric disorders;
  • history of long-term analgesic medication use;
  • severe cardiopulmonary disease;
  • severe uncontrolled infection;
  • incomplete medical records.

Treatment and study plan

hydrochloride hydromorphone + flurbiprofen axetil

Drug

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.

conventional analgesia

Drug

When the NRS score was ≥4, flurbiprofen axetil 50 mg was administered intravenously, with intramuscular tramadol 100 mg added if analgesia was inadequate.

Primary outcomes

  1. Perioperative numerical pain rating scale (NRS) score

    Time frame: 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 outcomes

  1. Surgical Duration

    Time frame: From the start of the operation to the end of the operation

    Total time from puncture initiation to completion of dressing (min).

  2. Adverse Events

    Time frame: 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.

  3. Analgesia Satisfaction

    Time frame: 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).

  4. Cost-Effectiveness Analysis

    Time frame: 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 outcomes

  1. Serum Inflammatory Markers

    Time frame: 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.

  2. Hepatic Function Indicators

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Collaborators

  • Affiliated Cancer Hospital & Institute of Guangzhou Medical University
  • Jinshazhou Hospital of Guangzhou University of Chinese Medicine

Registry information

Official study title

Enhanced Recovery After Surgery-Based Multimodal Preemptive Analgesia for Perioperative Management in Transarterial Chemoembolization of Intermediate-to-Advanced Hepatocellular Carcinoma: a Multicenter Retrospective Cohort Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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