Department of Radiology, Hôpital Beaujon, AP-HP.Nord, 92110 Clichy, France.
Department of Radiology, Hôpital Beaujon, AP-HP.Nord, 92110 Clichy, France; Université Paris Cité, INSERM U1149, "Centre de Recherche sur l'Inflammation", CRI, 75018 Paris, France; FHU MOSAIC, 92110 Clichy, France.
Diagn Interv Imaging. 2023 Mar;104(3):123-132. doi: 10.1016/j.diii.2022.10.013. Epub 2022 Nov 18.
The purpose of this study was to assess the performance of a reinforced analgesic protocol (RAP) on pain control in patients undergoing conventional trans-arterial chemoembolization (cTACE) for hepatocellular carcinoma (HCC).
Eighty-one consecutive patients (57 men, 24 women) with a mean age of 69 ± 10 (standard deviation) years (age range: 49-92 years) underwent 103 cTACEs. Standard antalgic protocol (50 mg hydroxyzine, 10 mg oxycodone, 8 mg ondansetron, and lidocaine for local anesthesia) was prospectively compared to a RAP (standard + 40 mg 2-h infusion nefopam and 50 mg tramadol). The individual pain risk was stratified based on age, the presence of cirrhosis and alcoholic liver disease, and patients were assigned to a low-risk group (standard protocol) or high-risk group (RAP). The primary endpoint was severe periprocedural abdominal pain (SAP), defined as a visual analog scale score ≥30/100. A predefined intermediate analysis was performed to monitor the benefit-risk of the RAP. Based on the intermediate analysis, all patients were treated with the RAP.
The intermediate analysis performed after 52 cTACE showed that 2/17 (12%) high-risk patients (i.e., those receiving the RAP) experienced SAP compared to 15/35 (43%) low-risk patients (odds ratio [OR] = 0.18; 95% confidence interval [CI]: 0.02-0.98; P = 0.03). Analysis of all procedures showed that 12/67 (18%) patients in cTACE receiving the RAP experienced SAP compared to 15/36 (42%) patients who did not receive it (OR = 3.27; 95% CI: 1.32-8.14; P = 0.01). There were no statistical differences in adverse events, particularly for nausea, between groups.
Reinforcing the analgesic protocol by combining non-opioid and opioid molecules reduces perioperative pain in patients undergoing cTACE for HCC.
本研究旨在评估强化镇痛方案(RAP)在接受常规经动脉化疗栓塞(cTACE)治疗肝细胞癌(HCC)患者中的疼痛控制效果。
81 例连续患者(57 例男性,24 例女性),平均年龄 69±10 岁(标准差)(年龄范围:49-92 岁)接受了 103 次 cTACE。前瞻性比较标准镇痛方案(50mg 羟嗪、10mg 羟考酮、8mg 昂丹司琼和利多卡因行局部麻醉)和 RAP(标准方案+40mg 2 小时输注奈福泮和 50mg 曲马多)。根据年龄、肝硬化和酒精性肝病的存在对个体疼痛风险进行分层,并将患者分配到低风险组(标准方案)或高风险组(RAP)。主要终点是围手术期严重腹痛(SAP),定义为视觉模拟评分≥30/100。进行了预设的中间分析以监测 RAP 的获益-风险比。基于中间分析,所有患者均接受 RAP 治疗。
在 52 次 cTACE 后进行的中间分析显示,17 例高风险患者(即接受 RAP 的患者)中有 2 例(12%)发生 SAP,而 35 例低风险患者中有 15 例(43%)(比值比[OR] = 0.18;95%置信区间[CI]:0.02-0.98;P = 0.03)。对所有手术的分析显示,接受 RAP 的 67 例 cTACE 患者中有 12 例(18%)发生 SAP,而未接受 RAP 的 36 例患者中有 15 例(42%)(OR = 3.27;95%CI:1.32-8.14;P = 0.01)。两组间在不良事件,尤其是恶心方面,无统计学差异。
通过联合非阿片类和阿片类药物强化镇痛方案可降低 HCC 患者行 cTACE 的围手术期疼痛。