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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Perioperative numerical pain rating scale (NRS) score
研究概览
简要总结
To evaluate the effectiveness of the combination of hydrochloride hydromorphone and flurbiprofen ester for post-TACE intravenous patient-controlled intravenous analgesia (PCIA).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
A:hydromorphone + flurbiprofen axetil
Group A received hydromorphone hydrochloride combined with flurbiprofen axetil via PCIA. Hydromorphone hydrochloride 6 mg (2 mL:2 mg, Hubei Yichang Humanwell Pharmaceutical) + flurbiprofen axetil 50 mg (5 mL:50 mg, Beijing Tide Pharmaceutical) were diluted with normal saline to 100 ml and loaded into a PCIA pump (48-h cycle). 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. Patients could self-administer boluses when the numerical pain rating scale (NRS) score was ≥4, with repeated presses during lockout having no effect. For patients with an NRS score ≥4 after two effective boluses, hydromorphone 1 mg diluted in normal saline to 10 ml was administered as a slow push over 2-3 min.
干预措施: hydrochloride hydromorphone + flurbiprofen axetil (Drug)
conventional analgesia
Group B received on-demand analgesia. When the NRS score was ≥4, flurbiprofen axetil 50 mg was administered intravenously, with intramuscular tramadol 100 mg added if analgesia was inadequate.
干预措施: conventional analgesia (Drug)
结局指标
主要结局
Perioperative numerical pain rating scale (NRS) score
时间窗: 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).
次要结局
- Surgical Duration(From the start of the operation to the end of the operation)
- Adverse Events(From the start of the operation to 24 hours after the operation)
- Analgesia Satisfaction(At 24 hours postoperatively)
- Cost-Effectiveness Analysis(From the start of the operation to the end of perioperative period)
研究者
Jiaping Li
Chief Physician
First Affiliated Hospital, Sun Yat-Sen University