Effect of intravenous lidocaine on nociception level-directed management in robot-assisted laparoscopic radical prostatectomy: protocol for a single-centre, factorial-randomised controlled trial (VALINOR study)

IF 0.8 Q3 ANESTHESIOLOGY

Anaesthesia reports Pub Date : 2025-09-19 DOI:10.1002/anr3.70027

H. Matsuura, N. Tanaka, Y. Sasaki, T. Kotani, Y. Yamamoto, M. Ida, M. Kawaguchi

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Abstract

Study Objective

To evaluate the efficacy of intra-operative lidocaine administration combined with nociception level-guided opioid management and to compare two minimum remifentanil infusion rate limits (0.11 vs. 0.05 μg.kg⁻¹.min⁻¹) during robot-assisted radical prostatectomy.

Design

Single-centre, double-blinded, two-by-two factorial randomised controlled trial.

Setting

Operating theatres at Nara Medical University Hospital, Nara, Japan.

Participants

Eighty-four adult patients scheduled for elective robot-assisted radical prostatectomy were participated in the study.

Interventions

Participants will be randomised into four groups (lidocaine/0.11, lidocaine/0.05, placebo/0.11 and placebo/0.05). All groups will receive nociception level-guided intra-operative opioid management.

Measurements

The primary outcome is the numerical rating scale score during movement 2 hours after surgery. Secondary outcomes include plasma concentrations of peri-operative inflammatory biomarkers (interleukin-6, cortisol and C-reactive protein), intra-operative remifentanil consumption, Quality of Recovery-15 scores (pre-operative and postoperative days 1 and 2), postoperative numerical rating scale scores up to postoperative day 7, peri-operative fentanyl consumption and the presence of prolonged postoperative pain at 3 months.

Hypothesis

Lidocaine will decrease intra-operative remifentanil requirements and early postoperative pain without increasing the inflammatory biomarker levels and the minimum remifentanil infusion rate limit will not significantly impact clinical outcomes.

Conclusion

This trial will evaluate the effects of intra-operative lidocaine administration and minimum remifentanil infusion rate limit based on nociception level-guided opioid management in patients undergoing robot-assisted radical prostatectomy.

Trial Registration

Japan Registry of Clinical Trials, jRCTs052240226 (registered on 26 December 2024, https://jrct.mhlw.go.jp/latest-detail/jRCTs052240226).

Ethics Approval

This protocol was approved by the Certified Review Board of Nara Medical University on 11 December 2024 (nara0063).

Study Period

Recruitment is planned from January 2025 to December 2026, with final follow-up completed in March 2027.

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静脉注射利多卡因对机器人辅助腹腔镜根治性前列腺切除术中痛觉水平导向管理的影响：一项单中心、因素随机对照试验方案（VALINOR研究）

目的评价术中利多卡因联合伤害感受水平引导下阿片类药物管理的疗效，并比较两种瑞芬太尼最低输注速率下限（0.11 vs 0.05 μg.kg−¹）。Min−¹)在机器人辅助根治性前列腺切除术期间。设计单中心、双盲、二乘二因子随机对照试验。日本奈良医科大学医院的手术室设置。84名成年患者计划接受选择性机器人辅助根治性前列腺切除术。受试者将随机分为四组（利多卡因/0.11、利多卡因/0.05、安慰剂/0.11和安慰剂/0.05）。所有组均接受伤害感觉水平引导的术中阿片类药物管理。主要观察指标为术后2小时运动时的数值评定量表评分。次要结局包括围术期炎症生物标志物（白细胞介素-6、皮质醇和c反应蛋白）血浆浓度、术中瑞芬太尼消耗、恢复质量-15评分（术前和术后第1天和第2天）、术后数字评定量表评分至术后第7天、围术期芬太尼消耗和术后3个月是否存在延长的疼痛。假设利多卡因会减少术中瑞芬太尼的需求和术后早期疼痛，而不会增加炎症生物标志物水平，最低瑞芬太尼输注速率限制不会显著影响临床结果。结论本试验将评估基于伤害感受水平引导的阿片类药物管理在机器人辅助根治性前列腺切除术患者术中给予利多卡因和瑞芬太尼最低输注速率限制的效果。日本临床试验注册中心，jRCTs052240226（于2024年12月26日注册，https://jrct.mhlw.go.jp/latest-detail/jRCTs052240226）。本方案于2024年12月11日获得奈良医科大学认证审查委员会批准（nara0063）。招聘时间为2025年1月至2026年12月，最终随访时间为2027年3月。

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来源期刊

Anaesthesia reports

CiteScore

1.30

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0.00%

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