Amsterdam UMC, University of Amsterdam, Department of Surgery, Amsterdam, the Netherlands.
Cancer Center Amsterdam, Amsterdam, the Netherlands.
Clin Transl Gastroenterol. 2024 Sep 1;15(9):e1. doi: 10.14309/ctg.0000000000000760.
Refractory pain is a major clinical problem in patients with pancreatic ductal adenocarcinoma (PDAC) and chronic pancreatitis (CP). New, effective therapies to reduce pain are urgently needed. Intravenous lidocaine is used in clinical practice in patients with PDAC and CP, but its efficacy has not been studied prospectively.
Multicenter prospective nonrandomized pilot study included patients with moderate or severe pain (Numeric Rating Scale ≥ 4) associated with PDAC or CP in 5 Dutch centers. An intravenous lidocaine bolus of 1.5 mg/kg was followed by continuous infusion at 1.5 mg/kg/hr. The dose was raised every 15 minutes until treatment response (up to a maximum 2 mg/kg/hr) and consecutively administered for 2 hours. Primary outcome was the mean difference in pain severity, preinfusion, and the first day after (Brief Pain Inventory [BPI] scale 1-10). A BPI decrease ≥1.3 points was considered clinically relevant.
Overall, 30 patients were included, 19 with PDAC (63%) and 11 with CP (37%). The mean difference in BPI at day 1 was 1.1 (SD ± 1.3) points for patients with PDAC and 0.5 (SD ± 1.7) for patients with CP. A clinically relevant decrease in BPI on day 1 was reported in 9 of 29 patients (31%), and this response lasted up to 1 month. No serious complications were reported, and only 3 minor complications (vertigo, nausea, and tingling of mouth). Treatment with lidocaine did not impact quality of life.
Intravenous lidocaine in patients with painful PDAC and CP did not show an overall clinically relevant reduction of pain. However, this pilot study shows that the treatment is feasible in this patient group and had a positive effect in a third of patients which lasted up to a month with only minor side effects. To prove or exclude the efficacy of intravenous lidocaine, the study should be performed in a study with a greater sample size and less heterogeneous patient group.
难治性疼痛是胰腺导管腺癌（PDAC）和慢性胰腺炎（CP）患者的主要临床问题。急需新的、有效的疗法来减轻疼痛。静脉注射利多卡因在 PDAC 和 CP 患者的临床实践中被使用，但它的疗效尚未被前瞻性研究。
多中心前瞻性非随机试验纳入了 5 个荷兰中心的 30 例中重度疼痛（数字评分量表≥4）相关的 PDAC 或 CP 患者。静脉给予 1.5mg/kg 的利多卡因负荷量，随后以 1.5mg/kg/hr 的速度持续输注。每 15 分钟增加一次剂量，直到达到治疗反应（最高可达 2mg/kg/hr），并连续输注 2 小时。主要结局是输注前后的平均疼痛严重程度差异（BPI 量表 1-10）。BPI 下降≥1.3 分被认为具有临床意义。
总体而言，30 例患者纳入研究，其中 19 例为 PDAC（63%），11 例为 CP（37%）。PDAC 患者在第 1 天的 BPI 平均差异为 1.1 分（SD ± 1.3），CP 患者为 0.5 分（SD ± 1.7）。29 例患者中有 9 例（31%）报告了第 1 天的 BPI 有临床意义的下降，这种反应持续了 1 个月。没有报告严重的并发症，只有 3 例轻微的并发症（眩晕、恶心和口腔麻木）。利多卡因治疗没有影响生活质量。
静脉注射利多卡因对伴有疼痛的 PDAC 和 CP 患者并没有显示出总体上具有临床意义的疼痛缓解。然而，这项初步研究表明，该治疗方法在该患者群体中是可行的，并且对三分之一的患者有积极的影响，这种影响持续了 1 个月，只有轻微的副作用。为了证明或排除静脉注射利多卡因的疗效，应该在更大的样本量和更少异质性患者群体的研究中进行。
